MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET TPRD HEX SCDR U-JOINT; HIP INSTRUMENTS : SCREWDRIVERS

Catalog Number 227463000

Device Problem Break (1069)

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

Event Date 04/21/2024

Event Type  malfunction  

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 synthese, or its employees that the report constitutes an admission that the product, depuy synthese, 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.

Event Description

It was reported that screwdriver broke in (b)(4) pieces, no patient effect or surgical delay.

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: according to the information received, it was reported that during screw insertion surgeon complained of driver shaft being very stiff and not rotating and articulating properly.Surgeon requested it be replaced.There were no delays during surgery.The device associated with this report was returned to depuy synthes for evaluation.Visual examination of the returned device revealed that the fork tip hex of the quickset tprd hex scdr u-joint (227463000) fell off and was not returned for evaluation, confirming the broken condition.The device exhibits an overall worn appearance consistent with normal and repetitive usage.However, taking in consideratiothat the device is more than 16 years old, the potential cause can be attributed to use and service over the year.According to the ifu (ifu-0902-00-836), end of useful instrument life is generally determined by wear or damage during surgical use.Care should be taken to regularly inspect components for damage prior to use.Any device that exhibits cracks or other damage which would compromise structural integrity or usability of the device should be discarded.A functional test was unable to be performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the quickset tprd hex scdr u-joint would contribute to the complained device 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 proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.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 (a1107) provided is not a valid finished goods lot#.

• Brand Name: QUICKSET TPRD HEX SCDR U-JOINT
• Type of Device: HIP INSTRUMENTS : SCREWDRIVERS
• 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 ; 3035526892
• MDR Report Key: 19197310
• MDR Text Key: 341431019
• Report Number: 1818910-2024-09295
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109365
• UDI-Public: 10603295109365
• 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: 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: 227463000
• Device Lot Number: A1107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/21/2024; 06/13/2024
• Supplement Dates FDA Received: 05/22/2024; 06/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2007
• 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