MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET FLEX DR SFT QCK CPLE; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 227452000

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Total hip replacement, (b)(6) hospital, (b)(6) 2018.It was reported that the drill bit wouldn¿t stay in the flexible drill shaft, resulting in the drill bit falling out mid way through drilling.Another drill bit and solid drill shaft was used.No ae to patient, no delay in surgery.Patient id: (b)(6).Male.

Manufacturer Narrative

(b)(4).The instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, will be filed as appropriate.

• Brand Name: QUICKSET FLEX DR SFT QCK CPLE
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7479581
• MDR Text Key: 107121017
• Report Number: 1818910-2018-58748
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109273
• UDI-Public: 10603295109273
• 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: 04/09/2018

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: 227452000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1