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

Catalog Number A6779

Device Problem Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 01/19/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

(b)(6) 2018.Thr, corail pinnacle, ceramic on ceramic.Size 13 standard 135 collared stem.52 gription sector cup with 52od 36id ceramic liner.Corail implant was sitting 5mm proud - the surgeon requested extraction instrumentation.Found it was difficult to thread "corail threaded adapter" into the implant for extraction.The surgeon was eventually able to screw the corail threaded adapter into the corail implant.Surgeon's concerns: no hole for a tommy bar in corail threaded adapter.Found gt was in the way when trying to screw into implant.The surgeon suggested the taper at the end of the corail threaded adapter be extended to allow more space to insert.Delayed surgery by one minute.No ae to patient.

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: 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 US; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 19380 ; 6103142063
• MDR Report Key: 7519690
• MDR Text Key: 108493141
• Report Number: 1818910-2018-59792
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• 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?: Yes
• Date Manufacturer Received: 12/12/2018
• 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