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

Catalog Number 205516000

Device Problems Structural Problem (2506); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that the clip is too elastic and will not lock.Surgical delay was unknown.

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).Investigation summary : an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary it was reported that the clip is too elastic and will not lock.Surgical delay was unknown.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that bipolar trl retaining clip 28 was found bent causing to not lock correctly.No other defect was found.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 investigation findings, the root cause is traced to design.The product issue has been 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 related nr was raised to address this issue.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18036114
• MDR Text Key: 326931232
• Report Number: 1818910-2023-21995
• 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,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205516000
• Device Lot Number: HW90103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2020
• 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 Age: 84 YR
• Patient Sex: Female