MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US BIPOLAR TRL RETAINING CLIP 28; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 205516000

Device Problem Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 04/16/2024

Event Type  malfunction  

Event Description

It was reported that the instrument ring warped.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that the instrument ring warped.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that bipolar trl retaining clip 28' circumference is smaller than the specified.Additionally, device had deep scratches at one side of device, where one of those scratches caused deformation on one of the pin holes.The discrepancy of the device circumference was traced to design, as material extruded was changing in the field after autoclaving.The potential cause for the scratched condition can be attributed to component failure, as condition may happen as a consequence of the discrepancy on the device.A dimensional inspection was performed for the bipolar trl retaining clip 28 and not met specifications.A functional test was unable to be performed as the mating device was not returned.The overall complaint was confirmed as the observed condition of the bipolar trl retaining clip 28 would contribute to the complained device issue.¿ based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found a nc associated with this product/lot combination.

• Brand Name: BIPOLAR TRL RETAINING CLIP 28
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19190475
• MDR Text Key: 341164747
• Report Number: 1818910-2024-09178
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295084501
• UDI-Public: 10603295084501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205516000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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