MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET FLEX DR SFT QCK CPLE; HIP INSTRUMENT/TRIAL

Catalog Number 227452000

Device Problem Break (1069)

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

Event Date 11/16/2016

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.(b)(4).This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

The shaft has become unraveled.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Manufacturer Narrative

Examination of the returned instrument confirmed the complaint; the wired shaft starting to unravel at the proximal end of the drill holder.The root cause is attributed to wear out.The date code ag0900 indicates the instrument was manufactured in (b)(6) of 2000 and is over 16 years old.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.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 INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6109556
• MDR Text Key: 60238698
• Report Number: 1818910-2016-31659
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2016

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: AG0900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/04/2016; 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2000
• 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