MAUDE Adverse Event Report: DEPUY FRANCE SAS 3003895575 SLAP HAMMER M6/M10 ADAPTATOR; CORAIL KAR INSTRUMENTS : ADAPTORS

Catalog Number A6779

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

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

Total hip replacement/ revision sjog murdoch (b)(6) 2018.In cssd it was noticed the threaded tip from this adapter was missing, this requires replacement for use.No patient involved.

Manufacturer Narrative

(b)(4).Examination of the affected product was not possible as the product was not returned for analysis.Based on the information received and the investigation performed, the root cause of the issue reported could not be determined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SLAP HAMMER M6/M10 ADAPTATOR
• Type of Device: CORAIL KAR INSTRUMENTS : ADAPTORS
• Manufacturer (Section D): DEPUY FRANCE SAS 3003895575; 7 allée irène joliot curie; bp 256; saint priest cedex 69801 ; FR 69801
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; bp 256; warsaw IN 46582 0998
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0998 ; 5743725905
• MDR Report Key: 7263232
• MDR Text Key: 99988477
• Report Number: 1818910-2018-53235
• Device Sequence Number: 1
• Product Code: FZY
• UDI-Device Identifier: 10603295255611
• UDI-Public: 10603295255611
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A6779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2018
• Date Device Manufactured: 06/10/2009
• 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