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

Model Number MCPX-40

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that the implant was broken into two pieces.This was noted following removal from a patient's finger.

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 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)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9213369
• MDR Text Key: 170321043
• Report Number: 0008031020-2019-01479
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385025377
• UDI-Public: 00886385025377
• Combination Product (y/n): N
• PMA/PMN Number: K013629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention