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

Catalog Number	123420000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem 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.
Additional 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
• Common Device Name: FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.18118910; 700 orthopaedic drive; warsaw IN 46582
• MDR Report Key: 6766997
• Report Number: 1818910-2017-22266
• Device Sequence Number: 1771304
• Product Code: KYJ
• UDI-Device Identifier: 10603295017967
• UDI-Public: 10603295017967
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 123420000
• Device Lot Number: 372995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR