MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET TPRD HEX SCDR CARDAN; HIP INSTRUMENTS : SCREWDRIVERS

Catalog Number 227449000

Device Problem Dull, Blunt (2407)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2018

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

On (b)(6) 2018.Surgeon was using the pinnacle screw set for screw placement during a corail pinnacle.The drill bit on the flexible one piece drill bit snapped during use, the screw drivers were all reported by the surgeon to be damaged - his words "stripped" - and unacceptable for their purpose, the ratchet handle was jammed and unable to be used as designed.This resulted in extra time being taken during the surgery to try each screw driver in turn, removing and reinserting the screws and deciding how best to proceed.(b)(6) representative was present at the case.The screws were eventually inserted but the instrumentation did not fulfill its function and it took some effort on behalf of the surgeon to ensure the screws were secure.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 potential event described in this report.Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate. .

• Brand Name: QUICKSET TPRD HEX SCDR CARDAN
• Type of Device: HIP INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8216867
• MDR Text Key: 132058085
• Report Number: 1818910-2019-79852
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10603295109259
• UDI-Public: 10603295109259
• 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: 12/07/2018

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: 227449000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1