MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 LOCKING SCREWDRIVER BODY; EXTREMITY INSTRUMENTS : SCREWDRIVERS

Catalog Number 230792003

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/09/2024

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 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.

Event Description

It was reported on inserting delta xtend locking screws, the green screwdriver #230792003 tongs on the end of the screwdriver broke off.Reverse shoulder replacement surgery was delayed 10 minutes due to the reported event.

• Brand Name: LOCKING SCREWDRIVER BODY
• Type of Device: EXTREMITY INSTRUMENTS : SCREWDRIVERS
• 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: 19165509
• MDR Text Key: 341156108
• Report Number: 1818910-2024-08464
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295116561
• UDI-Public: 10603295116561
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

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: 230792003
• Device Lot Number: 5209164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2013
• 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