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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX SRL ROD CLIP CLAMP
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ORTHOFIX SRL ROD CLIP CLAMP Back to Search Results
Model Number 1
Device Problem Mechanical Problem (1384)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the component code 92015 lot b1357393 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00001 and 9680825-2020-00002).Orthofix (b)(4) checked the internal records related to the controls made on the component code 92015 lot b1351455 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00003 and 9680825-2020-00004).Orthofix (b)(4) checked the internal records related to the controls made on the component code 92015 lot b1357338 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00005).Orthofix (b)(4) checked the internal records related to the controls made on the component code 92015 lot b1285509 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr report 9680825-2020-00006).Orthofix (b)(4) checked the internal records related to the controls made on the component code 92015 lot b1266743 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr report 9680825-2020-00007).Orthofix (b)(4) checked the internal records related to the controls made on the component code 92011 lot b1304019 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00008 and 9680825-2020-00009).Orthofix (b)(4) checked the internal records related to the controls made on the component code 92011 lot b1282257 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00010).Technical evaluation: the technical evaluation on the returned devices, received on january 14, 2020, is currently on going.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once further information/clarification and/or the results of the technical evaluation become available.Orthofix (b)(4) has requested the local distributor to provide further details such as date of the initial surgery.Adverse effects caused to patient (loss of fracture reduction?) date of the devices failure.Did the ten clamps fail at the same time? date of the second surgery.Copy of x-ray images.Confirmation that the patient is well.Unfortunately, this information has not yet made available.As soon as further information and/or the results of the technical investigation are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.
 
Event Description
The information provided by the local distributor indicates: devices code: seven devices code 92015 (screw clip clamp) and three devices code 92011 (rod clip clamp).Batch numbers: b1357393 (qty 2) - b1351455 (qty 2) - b1357338 (qty 1) - b1285509 (qty 1) - b1266743 (qty 1) - b1304019 (qty 2) - b1282257 (qty 1).Total quantity: ten (mfr reports from 9680825-2020-00001 to 9680825-2020-00010 reflecting the sequence of the batch numbers listed above).Hospital name: (b)(6).Surgeon name: dr (b)(6).Date of initial surgery: not provided.Body part to which device was applied: tibia fracture.Surgery description: fracture treatment.Patient information: (b)(6) years, male, in good health condition.Problem observed during: on scheduled device removal.Type of problem: device functional problem.Event description: "tibia fracture was caused by traffic accident injury, and then external fixation was performed.About one week after fixation, the patient and the doctor found that prefix rod clamp were broken, resulting in a decrease in stability".The complaint report form also indicated: the device failure had adverse effects on patient (adverse effects not specified).The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required (date not provided).A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: "at the current stage, the patient has been left the hospital".Manufacturer ref: (b)(4).
 
Event Description
The information provided by the local distributor indicates: devices code: seven devices code: 92015 (screw clip clamp) and three devices code: 92011 (rod clip clamp).Batch numbers: b1357393, (qty 2) - b1351455 (qty 2), b1357338 (qty 1), b1285509 (qty 1), b1266743 (qty 1), b1304019 (qty 2), b1282257 (qty 1).Total quantity: ten (mfr reports from 9680825-2020-00001 to 9680825-2020-00010 reflecting the sequence of the batch numbers listed above).Hospital name: (b)(6).Date of initial surgery: not provided.Body part to which device was applied: tibia fracture.Surgery description: fracture treatment.Patient information: 57 years, male, in good health condition.Problem observed during: on scheduled device removal.Type of problem: device functional problem.Event description: "tibia fracture was caused by traffic accident injury, and then external fixation was performed.About one week after fixation, the patient and the doctor found that prefix rod clamp were broken, resulting in a decrease in stability".The complaint report form also indicated: the device failure had adverse effects on patient (adverse effects not specified).The initial surgery was completed with the device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required (date not provided).A medical intervention (outpatient clinic) was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: "at the current stage, the patient has been left the hospital".Manufacturer ref: (b)(4).
 
Manufacturer Narrative
Analysis of historical records: orthofix srl checked the internal records related to the controls made on the component code: 92015, lot: b1357393 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00001 and 9680825-2020-00002).Orthofix srl checked the internal records related to the controls made on the component code: 92015, lot: b1351455 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00003 and 9680825-2020-00004).Orthofix srl checked the internal records related to the controls made on the component code: 92015, lot: b1357338 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr repors 9680825-2020-00005).Orthofix srl checked the internal records related to the controls made on the component code: 92015, lot: b1285509 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr report 9680825-2020-00006).Orthofix srl checked the internal records related to the controls made on the component code: 92015, lot: b1266743 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr report 9680825-2020-00007).Orthofix srl checked the internal records related to the controls made on the component code: 92011, lot: b1304019 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00008 and 9680825-2020-00009).Orthofix srl checked the internal records related to the controls made on the component code: 92011, lot: b1282257 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot (mfr reports 9680825-2020-00010).Technical evaluation: the returned devices, received on january 14, 2020, were examined by orthofix srl quality engineering department.All the returned devices were subjected to visual check as per orthofix specification.The visual check confirmed the problem notified: all devices evidenced a crack on the external surface.A functional check on the returned devices was not possible as the devices are broken and therefore not functioning.It was also performed the documental verification of the certificate of the raw material used to produce the devices involved.No issues have been detected.From a verification of the crack surfaces, the technical investigation concluded that the failure of the returned clamps is mainly attributable to intergranular corrosion that caused exfoliation and breakage under load.This corrosion is most likely to be attributable to the use of aggressive cleaning agents.Medical evaluation: the information made available on the event together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed.On (b)(6) 2020: "it seems that perhaps all of the clamps on this patient failed suddenly one week after application.We are told that 7 of the (b)(4) units and (b)(4) of the (b)(4) units failed.The fracture position was lost and the fixation needed to be revised in a second surgery.Assuming that the clamps were applied correctly initially, this patient must have been involved in a sudden event which loaded the fixator so that most or all of the clamps failed.We need more details before we can make sense of this very unusual event".February 3, 2020 with the results of the technical evaluation: "as anticipated, all of the clamps in this patient failed, and we can now see why: they all had a crack in the material of the rod clamp, which would have resulted in failure of fixation.The technical report shows that the clamps were subject to intergranular corrosion which has caused exfoliation of the aluminium alloy, weakening it and causing the failures.So we have the following information: 1.Failure rates of these clamps are very low.2.From the records we know that these items were originally manufactured fully to specification.3.We now know that the items were all subject to corrosion, which was almost certainly initiated by the use of an incorrect chemical during cleaning or disinfection.4.We need to remind the distributor and the hospital of the reprocessing advice contained in pq_isp.Conclusion: corrosion caused by incorrect processing, weakening the metal and leading to breakage".Final comments: the technical investigation concluded that the failure of the returned clamps is mainly attributable to intergranular corrosion that caused exfoliation and breakage under load.This corrosion is most likely to be attributable to the use of aggressive cleaning agents.A complete medical evaluation was not possible as no information about the medical procedure, diagnosis and x-rays have been made available.Orthofix requested further details on the event such as: 1.Date of the initial surgery.2.Adverse effects caused to patient (loss of fracture reduction)? 3.Date of the devices failure.4.Did the ten clamps fail at the same time? 5.Date of the second surgery.6.Copy of x-ray images.7.Confirmation that the patient is well.Unfortunately, this information was not made available.Orthofix would like to remind that the instructions for the safe processing of orthofix medical devices are included in the relevant instructions for use leaflet, re.Pq isp.The analysis of the historical data evidenced that no other notifications have been received on devices belonging to these specific lots.Orthofix continues monitoring the products on the market.
 
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Brand Name
ROD CLIP CLAMP
Type of Device
ROD CLIP CLAMP
Manufacturer (Section D)
ORTHOFIX SRL
via delle nazioni, 9
bussolengo, verona, 37012
IT  37012
MDR Report Key9626995
MDR Text Key190482070
Report Number9680825-2020-00008
Device Sequence Number1
Product Code JDW
UDI-Device Identifier18032568867220
UDI-Public(01)18032568867220(11)190627(10)B1304019
Combination Product (y/n)N
PMA/PMN Number
K955848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1
Device Catalogue Number92011
Device Lot NumberB1304019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Date Manufacturer Received01/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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