MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET SCR HOLDING FORCEPS; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 227455000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Screw holding forceps broke whilst in use, inserting the acetabular screw.There was minimal force used, and the instrument only broke into 2 pieces which were retrieved.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the added:device manufactured date.Product complaint (b)(4).Investigation summary: the product was returned to the depuy australia engineering dept where it was assessed by the engineering technician.The product was deemed to have broken due to wear and tear.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: QUICKSET SCR HOLDING FORCEPS
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8951319
• MDR Text Key: 163339250
• Report Number: 1818910-2019-102696
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10603295109303
• UDI-Public: 10603295109303
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/12/2019

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: 227455000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR