MAUDE Adverse Event Report: ORTHOFIX SRL LOCKING ROD

Model Number 17930

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2016

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records.Orthofix srl checked the internal records related to the controls made on the device code 17930 lot e03 before the market release.No anomalies have been found.The original lot, manufactured in may 2007, was comprised of 50 units.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation: the technical evaluation on the returned portion of the broken device involved, received by orthofix srl on (b)(4) 2016, is currently on going.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available.Orthofix srl has requested the distributor to provide further information on the event such as patient's information, type of nail implanted, copies of the operative reports, copies of x-ray images, information on patient current health condition.Unfortunately, this information has not yet made available.As soon as further information is available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6) hospital; surgeon name: mr.(b)(6); date of surgery: (b)(6) 2016; body part to which device was applied: femur; surgery description: fracture treatment; patient's information: male; problem observed during: clinical use on patient/intraoperative.Event description: the locking rod sheared and broke during the procedure and consequently the broken portion had to be left in the nail at the end of the operation.The surgeon feels this is a wear and tear incident.I have recovered the hex end of the locking rod.The complaint report form indicates: the device failure did not have any adverse effects on patient; the surgery was completed with used device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was not required; copies of the operative report are not available; copies of the xrays images are not available; information on patient current health condition: n/a.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 17930 lot e03 before the market release.No anomalies have been found.The original lot, manufactured in may 2007, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first notification received from this specific device lot.Technical evaluation the returned portion of the broken device involved, received on february 15, 2016 was examined by orthofix srl quality engineering department.The device was subjected to visual and dimensional check as per orthofix srl design and product specifications.The visual check confirmed that the returned device was broken.The surface of the breakage can be related to an overtightening and flexional stress.The dimensional and the material checks confirmed that the device met the specifications.It was not possible to perform the functional check as the part is broken.Orthofix failure analysis concluded that the returned broken device was originally conforming to design specifications.The breakage occurred might be attributable to a combination of overtightening, flexional stress and wear and tear of the device (device manufactured in may 2007).Medical evaluation : the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluation: "the locking rod broke during nail insertion.The operation was completed with no loss of time, and a small piece of the locking rod remains attached to the nail.The surgeon feels that this is a wear and tear issue, and i expect that he is correct.The patient came to no harm and no time was lost.The small amount of locking rod left in the nail will not cause any problems." additional medical evaluation following the results of the technical analysis: "the technical analysis in this case shows clearly that this locking rod had been subject to very considerable wear and tear.The hex socket has been marked and deformed slightly by repeated stress.The comments in step 4 of pq_isp make it very clear that this instrument should have been discarded and not included in this instrument set.This locking rod should not have been used any more." "the stainless steel locking rod fragment is inside the titanium intramedullary nail and is completely unloaded, being simply a mechanically passive foreign body.I would therefore suspect that the fragment will not cause any problems even over a long period.I would conclude that there is no evidence in the current scientific literature that the theoretical galvanic effects of implant grade titanium and stainless steel are likely to cause any problems for the patient, particularly in this case where the stainless steel fragment is unloaded and not subject to any micromotion relating to the titanium implant.If the component is completely passive and not carrying any load, there should be no shear mechanism between the parts and in this case no harm will come, even if it is not implant grade.It is still stainless steel and should be inert." final comments: the results of the technical evaluation evidenced that the returned broken device was originally conforming to design specifications.The breakage occurred might be attributable to a combination of overtightening, flexional stress and wear and tear of the device (device manufactured in may 2007.) the medical evaluation evidenced as follow: "the technical analysis in this case shows clearly that this locking rod had been subject to very considerable wear and tear.The hex socket has been marked and deformed slightly by repeated stress.The comments in step 4 of pq_isp make it very clear that this instrument should have been discarded and not included in this instrument set.This locking rod should not have been used any more." orthofix srl would like to recommend observing the instructions included in the instructions for the safe processing of the orthofix® fixation system medical devices, ref.Pq isp.Step 4.Inspection, maintenance and testing: all instruments and product components should be visually inspected for cleanness and any signs of deterioration that may cause failure in use (such as cracks or damage to surfaces) and functions tested before being sterilized (see detailed operative technique manuals and instructions for use).If a component or instrument is believed to be faulty, damaged or suspect, it should not be used.Based on the results of the technical evaluation performed on the returned device, that evidenced its conformity to orthofix srl design specifications, and on the evidences deriving from the medical evaluation, orthofix srl can conclude that the problem occurred is not device related.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: (b)(6).Date of surgery: (b)(6) 2016; body part to which device was applied: femur; surgery description: fracture treatment; patient's information: male; problem observed during: clinical use on patient/intraoperative; event description: the locking rod sheared and broke during the procedure and consequently the broken portion had to be left in the nail at the end of the operation.The surgeon feels this is a wear and tear incident.I have recovered the hex end of the locking rod.The complaint report form indicates: the device failure did not have any adverse effects on patient; the surgery was completed with used device; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was not required; copies of the operative report are not available; copies of the xrays images are not available; information on patient current health condition: n/a.(b)(4).

• Brand Name: LOCKING ROD
• Type of Device: LOCKING ROD
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012 ; 0456719000
• MDR Report Key: 5482979
• MDR Text Key: 39743820
• Report Number: 9680825-2016-00014
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 17930
• Device Catalogue Number: 17930
• Device Lot Number: E03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention