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

Model Number MCP-30

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

The customer reported a broken implant, the patient required a revision surgery.

Event Description

The customer reported a broken implant, the patient required a revision surgery.

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 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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: SILICONE II MCP IMPLANT SIZE 30 (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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12950049
• MDR Text Key: 281831712
• Report Number: 0008031020-2021-00491
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385022130
• UDI-Public: 00886385022130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K870200
• 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: 03/30/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MCP-30
• Device Catalogue Number: MCP30
• Device Lot Number: 15464D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2019
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female