MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HP UNIVERSAL HANDLE; KNEE INSTRUMENT : HANDLES

Catalog Number 950501305

Device Problem Mechanical Jam (2983)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

It was reported that the sigma impaction handle spring no longer works.

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.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 anterior portion broke off trial femur.Red tightening knob broke off.All pieces retrieved and there was no harm to the patient.Sigma impaction handle spring no longer works.The device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned device found that the spring of the hp universal handle was deformed it has already lost its elasticity, causing that the device does not works correctly.The observed condition of the device was consistent with repeated use through the 14 years of service.The overall complaint was confirmed as the observed condition of the hp universal handle would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the date code (a0409) provided is not a valid finished goods lot# corrected:.

• Brand Name: HP UNIVERSAL HANDLE
• Type of Device: KNEE INSTRUMENT : HANDLES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• 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: 18402910
• MDR Text Key: 331441110
• Report Number: 1818910-2023-26071
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10603295226031
• UDI-Public: 10603295226031
• 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
• Report Date: 12/27/2023

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: 950501305
• Device Lot Number: A0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/29/2024; 02/08/2024
• Supplement Dates FDA Received: 01/30/2024; 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2009
• 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: 67 YR
• Patient Sex: Male