MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 NEUFLEX MCP IMPLANT SZ 40; NEUFLEX IMPLANT : FINGER IMPLANT

Catalog Number	123440000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Additional 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.Investigation summary = > 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.Review of inspection criteria finds the product and lot combination met specification.Review of the did not reveal any related deviations or anomalies.Device history lot = > null.Device history lot = > null.Device history review = > null.
Event or Problem Description
Medwatch report received stated that mcp implant placed right index mp silastic arthroplasty.Patient experienced symptom relief a couple of months after.Later in the year, xrays reviewed arthroplasty well incorporated.Significant arthritis with deviation noted at rip joint.Patient seen with doctor, who reviewed treatment options including pip joint fusion vs working with hand ot to see how much mobility can recovered.Doctor warned that patient may develop increase pain at her pip joint while working on rom but patient is interested in proceeding.Plan for return to clinic in 2 months.Patient returned with increased pain and swelling.Fluoroscopic imaging obtain today shows the implant appears well seated in the proximal phalanx and metacarpal with no evidence of osteolysis.However it looks as though the implant may be broken at hinge.Doi: (b)(6) 2016; dor: (b)(6) 2017 affected side: unknown.

• Brand Name: NEUFLEX MCP IMPLANT SZ 40
• Common Device Name: NEUFLEX IMPLANT : FINGER IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7133910
• Report Number: 1818910-2017-52210
• Device Sequence Number: 19060619
• Product Code: KYJ
• UDI-Device Identifier: 10603295017981
• UDI-Public: 10603295017981
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K970544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: 123440000
• Device Lot Number: 723814
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• 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: 59 YR
• Patient Weight: 16