MAUDE Adverse Event Report: ORTHOFIX SRL ADV MICROMETRIC SWIVELLING CLAMP

Model Number 53115

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 device code 53115 lot v1415427 (lot laser marked on component 530520) before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation: the technical evaluation of the device involved will be performed as soon as the device becomes available.Medical evaluation: the information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once further information on the event are available.Orthofix (b)(4) has requested the distributor to provide further information on the event such as detailed event description, what treatment was performed after the device failure, and device availability for the technical evaluation.Unfortunately this information has not yet been made available.As soon as further information is available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.Device not returned yet.

Event Description

The information provided by the local distributor indicates: hospital name: hospital (b)(6); surgeon name: (b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied: femur left; surgery description: correction; patient information: (b)(6), female, previous health condition: good; problem observed during: clinical use on patient/intraoperative; type of problem: device functional problem; event description: failure head locking screw fatigue.The complaint report form indicates: the device failure had adverse effects on patient: loss of distraction/correction achieved; 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 required -(b)(6) 2016; a medical intervention (outpatient clinic) was not required; copies of the operative report are not available; copies of x-ray images are not available.Information on patient current health condition: submitted for a review.Further information received from the distributor on january 6, 2017: the event was informed to anvisa under 2017.01.000808.Please, consider this like an internal complaint reference number for this notification; the problem was identified by the physician in november 21st, 2016.The first surgery occurred in (b)(6) 2016.Therefore, the problem was identified 4 month after to the first surgery; there is not x-rays available, in according to dr.(b)(6), from (b)(6) hospital; in according to the physician, patient's health condition after surgery occurred in (b)(6) 2016, is good.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the (b)(4) lot v1415427 (lot laser marked on component 530520) before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been released to the market.According to orthofix (b)(4) historical records, this is the first notification received from this specific device lot.Technical evaluation the returned device, received on january 9th, 2017 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and functional check as per orthofix (b)(4) design and product specifications.The device was examined as received, i.E.Mounted.No anomalies were detected.Then, the red tape that was applied by the customer on the device was removed and again no defects were found.The device was then dismantled.No defects were found in the single components of the device.It could only be noticed that the device was not correctly cleaned because parts are dirty.The visual check on the screws (axial screws and m6x14.8 screws) did not evidence any signs of fatigue.The visual check evidenced that the device does not show any signs of fatigue.It could only be noticed that the device was not correctly cleaned because parts are dirty.The functional check was performed using ø6 mm screws, inserting them into the clamp and fixed in different positions.The functional test passed because the clamp can maintain the screws fixed.Orthofix failure analysis can conclude that the device returned was in conformity with orthofix (b)(4) specifications and that it is still functioning properly.Medical evaluation the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed.On 5 january 2017 "this case from (b)(6) is about a (b)(6) girl who had an lrs adv system applied to her left femur for an unspecified correction on (b)(6).A micrometric swivelling clamp was used, (b)(4), as part of the frame.At some point a screw on the clamp failed; this is unspecified, but cause loss of correction.A second operation was carried out on (b)(6); we have not been told what this was and what the result of the screw failure was.It may be that the swivelling clamp was locked after correction, and this was lost when the locking screw failed, but this is only guesswork.We also need to know how the torque was applied: did the surgeon use a torque wrench or a spanner / allen key.Why was it necessary at that stage to apply torque to the screw which failed? had it just come loose or was this just a general check on stability during a routine check? there are many questions and it would be nice to have some answers." on 6 february 2017 "the original very inadequate complaint form suggested that the locking screw of the swivelling clamp failed.However, we have been presented with a dirty but otherwise fully functional unit.I can imagine that the holding power of the swivelling clamp would not be as much as it should be if there is dirt between the surfaces.With the information supplied i suggest that we label this as incorrect processing." final comments orthofix failure analysis can conclude that the device returned was in conformity with orthofix (b)(4) specifications and that it is still functioning properly.A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i.E.Patient diagnosis, kind of treatment, copy of the x-ray images.Orthofix (b)(4) has requested the distributor to provide further information on the event such as detailed event description, what treatment was performed after the device failure, and copy of x-ray images.Unfortunately, this information was not provided.Based on the results of the technical evaluation performed that confirmed the device conformity to specifications, orthofix (b)(4) can conclude that the problem occurred is not device related.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: hospital (b)(6).Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2016.Body part to which device was applied: femur left.Surgery description: correction.Patient information: (b)(6), female, previous health condition: good.Problem observed during: clinical use on patient/intraoperative.Type of problem: device functional problem.Event description: failure head locking screw fatigue.The complaint report form indicates: the device failure had adverse effects on patient: loss of distraction/correction achieved; 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 required - (b)(6) 2016; a medical intervention (outpatient clinic) was not required; copies of the operative report are not available; copies of x-ray images are not available.Information on patient current health condition: submitted for a review.Further information received from the distributor on january 6, 2017: -the event was informed to (b)(6) under (b)(4).Please, consider this like an internal complaint reference number for this notification.-the problem was identified by the physician in (b)(6) 2016.The first surgery occurred in (b)(6) 2016.Therefore, the problem was identified 4 month after to the first surgery.- there is not x-rays available, in according to dr.(b)(6), from (b)(6) hospital.-in according to the physician, patient's health condition after surgery occurred in (b)(6) 2016, is good.(b)(4).

• Brand Name: ADV MICROMETRIC SWIVELLING CLAMP
• Type of Device: ADV MICROMETRIC SWIVELLING CLAMP
• 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: 6240224
• MDR Text Key: 64424913
• Report Number: 9680825-2017-00002
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K955848
• 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: 02/10/2017

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: 53115
• Device Catalogue Number: 53115
• Device Lot Number: V1415427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR