MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.033.003

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, when the consultant was preparing the set for sterilization it was noticed both of the plastic tabs on the side of the radiolucent aiming arm/frn greater trochanter were broken off.It is unsure where or when the damage took place.There was no patient involvement.This report is for one (1) radiolucent aiming arm/frn greater trochanter.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: the radiolucent aiming arm/frn greater trochanter (p/n: 03.033.003, lot number: l963559) was received at us cq.Upon visual inspection, both cam lock levers were missing from the device.There was no broken fragments remaining on the device or returned.The remainder of the device displayed no other alteration or damage.Device failure/defect identified? yes.Dimensional inspection: no dimension inspection was performed on the returned device due to the post manufacturing damage of the device.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the radiolucent aiming arm/frn greater trochanter (p/n: 03.033.003, lot number: l963559) was returned with both cam lock levers missing from the device.No broken fragments were found with the returned device or were still attached to it; hence the complaint is not confirmed.No definitive root cause could be attributed to the missing components based on the information received and the investigation conducted.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot part: 03.033.003, lot: l963559, manufacturing site: hägendorf, release to warehouse date: sep 27, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10347422
• MDR Text Key: 201427141
• Report Number: 2939274-2020-03330
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271075
• UDI-Public: (01)10886982271075
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.033.003
• Device Catalogue Number: 03.033.003
• Device Lot Number: L963559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1