MAUDE Adverse Event Report: STRYKER GMBH MCP PREFLEX IMPLANT SIZE 40 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number	MCPX-40
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the implant was broken into two pieces.This was noted following removal from a patient's finger.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the visual inspection showed that the implant is indeed broken in two parts.Moreover, signs of wear (scratches) are visible on the implant.However, more detailed information about the complaint event (such as x-rays and operative reports ) must be available in order to determine the root cause of the complaint event.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that the implant was broken into two pieces.This was noted following removal from a patient's finger.

• Brand Name: MCP PREFLEX IMPLANT SIZE 40 (STERILE PACKED)
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9213369
• Report Number: 0008031020-2019-01479
• Device Sequence Number: 19394349
• Product Code: KYJ
• UDI-Device Identifier: 00886385025377
• UDI-Public: 00886385025377
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K013629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: 03/31/2020
• Device Model Number: MCPX-40
• Device Catalogue Number: MCPX40
• Device Lot Number: 10221-L12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 02/17/2020
• 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