MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 QUICKSET RATCHET SCDR HDL; HIP INSTRUMENTS : HANDLES

Catalog Number 227402000

Device Problem Naturally Worn (2988)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

In a total hip replacement the cup inserted handle kept un the reading from the trials making it hard to impact.No issues as we managed to get the cup in.Also the ratchet has stopped working on the screw ratchet handle for pinnacle screw insertion.No adverse event, we used a large fragment screwdriver instead.Surgery was delayed 2 minutes due to the reported event.Action taken when event occurred? a different screwdriver was used / handle was just screwed really tight , was procedure successfully completed? yes, were fragments generated? no,.

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.

• Brand Name: QUICKSET RATCHET SCDR HDL
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• 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: 19151818
• MDR Text Key: 341155575
• Report Number: 1818910-2024-08710
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109020
• UDI-Public: 10603295109020
• 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: 04/22/2024

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: 227402000
• Device Lot Number: B5KB94000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2020
• 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