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

Catalog Number 952211500

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is under investigation.Depuy will notify the fda of the results of the investigation once it has been completed.Followup with the complainant has been conducted for the lot number, and the information is not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Broach handles not locking onto broaches.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint description states that the broach handles were not locking onto broaches.The devices associated to the complaint were not returned.It is reported that an engineering assessment was performed.The analysis concluded that there is extensive impaction damage to both the broach handles and also cracks can been seen around the pivot pins on both broach handles.The assessment is that this complaint is due to wear and tear.A search into the complaints database was performed, no other similar complaint was reported for the affected product codes and lots combinations.Based on the information received and the investigation performed, the root cause of the incident is due to wear and tear.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: CORAIL 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: 6192935
• MDR Text Key: 62977702
• Report Number: 1818910-2016-33787
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 952211500
• Device Lot Number: J0208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2008
• 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