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

Model Number PIP-30

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; hospital retained.

Event Description

It was reported that the patient's left hand was revised due to the size 30 proximal silicone pip instrument breaking.

Event Description

It was reported that the patient's left hand was revised due to the size 30 proximal silicone pip instrument breaking.

Manufacturer Narrative

Correction: refer to d4 lot number the reported event could be confirmed, only based on the picture received.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: 30 SILICONE PIP IMPLANT (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10423090
• MDR Text Key: 203495395
• Report Number: 0008031020-2020-02176
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021553
• UDI-Public: 00886385021553
• Combination Product (y/n): N
• PMA/PMN Number: K931588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: PIP-30
• Device Catalogue Number: PIP30
• Device Lot Number: 03268L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR