MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. EXTRA CURVED BROACH HANDLE; HIP INSTRUMENT/TRIAL

Catalog Number 259807550

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.(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

The broach handle has become loose.

Manufacturer Narrative

This complaint remains under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.

Manufacturer Narrative

A functional test with a mating broach confirmed the complaint; the handle no longer locks.The root cause is attributed to misuse and wear; damage to the cam component.It is important to ensure that the alignment features on both the handle and broach are mated correctly, as proper locking will extend the life of all broach handles.If these orientation features are not aligned properly, the cam will lock incorrectly onto the broach.After this type of deformation occurs, the handle will no longer lock as tightly onto the broach as when first distributed.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: EXTRA CURVED BROACH HANDLE
• Type of Device: HIP INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6057477
• MDR Text Key: 58409571
• Report Number: 1818910-2016-30225
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 259807550
• Device Lot Number: RA129A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2014
• 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