MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SLAP HAMMER M6/M10 ADAPTATOR; HIP INSTRUMENT

Catalog Number A6779

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

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.

Event Description

Instruments reported to me by (b)(6) ortho technician.Not related to specific case.The three corail threaded adaptors are not screwing into femoral stem.One of the adaptors is cross threaded and stuck on the extractor axis (with slap hammer in place (b)(4)).The pinnacle liner extractor - the metal tip that inserts into ard tabs of the shell appears to have broken off/worn down.Unable to use this instrument to extract liner without the ability to lock in to the ard tabs.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the instrument associated with this report was not returned.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SLAP HAMMER M6/M10 ADAPTATOR
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; bp 256; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7096900
• MDR Text Key: 94828761
• Report Number: 1818910-2017-50985
• Device Sequence Number: 1
• Product Code: FZY
• UDI-Device Identifier: 10603295255611
• UDI-Public: 10603295255611
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• 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: 5115165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Date Device Manufactured: 02/01/2012
• 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