MAUDE Adverse Event Report: STRYKER GMBH SILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number	MCP-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported: revision of a silicone mcp implant placed in (b)(6) 2019.The implant broke at the junction with the distal phalanx.For the patient a re-operation 4 months after the primary surgery.Patient experienced pain and deformity.
Additional Manufacturer Narrative
The reported event could be confirmed.The medical records were forwarded to a consulting health care professional for review.The comments based on the x-rays and the operative reports are the following: "i do not notice any abnormalities that could have attributed to this event.However, z-deformity or swanneck deformity as described here lead to a high instability of the pip and dip joint in the frontal plane.The dislocation of the flexor tendons to the dorsal aspect of the bone may contribute to high load on the implant." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.However, the real root cause of the reported event could not be determined.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported: revision of a silicone mcp implant placed in (b)(6) 2019.The implant broke at the junction with the distal phalanx.For the patient a re-operation 4 months after the primary surgery.Patient experienced pain and deformity.

• Brand Name: SILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED)
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9558366
• Report Number: 0008031020-2020-00095
• Device Sequence Number: 14014527
• Product Code: KYJ
• UDI-Device Identifier: 00886385022130
• UDI-Public: 00886385022130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K870200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2023
• Device Model Number: MCP-30
• Device Catalogue Number: MCP30
• Device Lot Number: 14983Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: 54 YR