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

Catalog Number 227463000

Device Problem Naturally Worn (2988)

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

Event Date 10/25/2023

Event Type  malfunction  

Event Description

It was reported that the swivel head screw driver shafts are stripped and worn.It was unknown if there was any surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that the pinnacle grater heads are dull per surgeon.Swivel head screw driver shafts are stripped and worn.It was unknown if there was any surgical delay the product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the quickset tprd hex scdr u-joint was found broken in middle of the tip.The broken fragment was not returned for examination.The device exhibits signs of normal use.No other issues were observed.Therefore, the reported condition cannot be confirmed.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a component failure that the potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.The overall complaint was not confirmed as the observed condition of the quickset tprd hex scdr u-joint would not contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error 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 synthese 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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.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.

• 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: 18440829
• MDR Text Key: 331867551
• Report Number: 1818910-2024-00257
• 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
• Report Date: 01/03/2024

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: SO2032782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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 Sex: Male