MAUDE Adverse Event Report: STRYKER GMBH MCP PREFLEX IMPLANT SIZE 50 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number MCPX-50

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 08/01/2022

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

It was reported that a revision took place due to recurrence of deformity.

Event Description

It was reported that a revision took place due to recurrence of deformity.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was wrong and the right one was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: MCP PREFLEX IMPLANT SIZE 50 (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15360744
• MDR Text Key: 299290872
• Report Number: 0008031020-2022-00427
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013629
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MCPX-50
• Device Catalogue Number: MCPX50
• Device Lot Number: 12678D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 11/30/2022
• Supplement Dates FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female