MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC.18118910 NEUFLEX MCP IMPLANT SZ 20; FINGER IMPLANT

Catalog Number 123420000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/07/2017

Event Type  Injury  

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

Der states that patient is very active in horseback riding, cleaning stalls, etc.Surgeon felt patient had disrupted her collateral ligaments and took in for repair.Surgeon found disrupted collaterals but also 3 of 4 mcp nuflex implants (index, middle, ring) had broken at the post.Two of these (index/middle) had been implanted on (b)(6) 2013.The ring surgeon had revised and implanted new on (b)(6) 2016.Surgeon.Believed implant failure due to implant postponing exasperated by collateral ligament failure.

Manufacturer Narrative

No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible for the unknown lot code(s).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: NEUFLEX MCP IMPLANT SZ 20
• Type of Device: FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.18118910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC.1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743725905
• MDR Report Key: 6766997
• MDR Text Key: 81814031
• Report Number: 1818910-2017-22266
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 10603295017967
• UDI-Public: 10603295017967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 123420000
• Device Lot Number: 372995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR