MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 BROACH CORAIL AMT 12; HIP INSTRUMENT/TRIAL

Catalog Number L20412

Device Problems Misconnection (1399); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

The trunion neck on the size 12 corail broach is oversized and would not allow the head/neck trials to seat on the trunion.

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.

Manufacturer Narrative

Additional narrative: examination of the returned instrument confirmed the complaint; deep circular scratching was found on the taper preventing from seating correctly onto a mating neck trial.The root cause is attributed to misuse.Deep circular scratching is due to the taper not being seated all the way into the broach handle before locking down on the lever locking mechanism of the broach handle.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: BROACH CORAIL AMT 12
• 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: 5987347
• MDR Text Key: 55940420
• Report Number: 1818910-2016-28456
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L20412
• Device Lot Number: SO2017024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2014
• 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
• Patient Age: 66 YR
• Patient Weight: 73