MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. PROXIMA MI CALCAR REAMER SMALL; HIP INSTRUMENT/TRIAL

Catalog Number 940080007

Device Problem Metal Shedding Debris (1804)

Patient Problem No Information (3190)

Event Date 07/20/2016

Event Type  malfunction  

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).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

After reaming the calcar the surgeon noted that there appeared to be metal filings around the circular rim of the reamer that were still attached to the reamer.

Manufacturer Narrative

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

Manufacturer Narrative

Examination of the returned instrument confirmed the complaint; it appears the reamer came into contact with another metal object.Provided information states the surgeon commented that the application of the broach was made difficult because of the surgical approach.A complaint database search finds no other reported incidents against the provided product and lot combination.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: PROXIMA MI CALCAR REAMER SMALL
• 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: 5843732
• MDR Text Key: 51060540
• Report Number: 1818910-2016-24427
• Device Sequence Number: 1
• Product Code: HTO
• 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: 08/22/2016

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: 940080007
• Device Lot Number: ABD83227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/26/2016; 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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