MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 QUICKSET FLEX DR SFT QCK CPLE; HIP INSTRUMENTS : INSERTION DEVICES

Catalog Number 227452000

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

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

Not catching the drill bit.

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.Investigation summary: examination of the returned instrument confirmed the complaint.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.

• Brand Name: QUICKSET FLEX DR SFT QCK CPLE
• Type of Device: HIP INSTRUMENTS : INSERTION DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US 1818910; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6103142063
• MDR Report Key: 8125251
• MDR Text Key: 129065801
• Report Number: 1818910-2018-76958
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10603295109273
• UDI-Public: 10603295109273
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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
• Device Lot Number: AG0802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2002
• 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