MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. SLAP HAMMER M6/M10 ADAPTATOR; HIP INSTRUMENT/TRIAL

Catalog Number A6779

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2017

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).See section d for any product information received.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

The surgeon attempted to thread the adapter to the implant, but the adapter was not able to connect to the implant in order to use the slap hammer to remove the implant.The surgeon instead had to use the extra implant extractor slap hammer to the screw in inserter in order to try to remove the implant.The surgeon stated the threading was worn out, and so it won't connect to the implant to make traction and remove the implant.No adverse events.

Manufacturer Narrative

The complaint description states that the adapter was not able to connect to the implant in order to use the slap hammer to remove the implant.The surgeon instead had to use the extra implant extractor slap hammer to the screw in inserter in order to try to remove the implant.The device associated to the complaint was not returned for analysis.No other analysis was possible because the batch number and the x-rays or medical records were not provided.Based on the information received and the investigation performed, the root cause of the incident could not be determined.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: SLAP HAMMER M6/M10 ADAPTATOR
• 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: 6360667
• MDR Text Key: 68412878
• Report Number: 1818910-2017-13548
• Device Sequence Number: 1
• Product Code: FZY
• 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
• Report Date: 02/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A6779
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 71 YR