MAUDE Adverse Event Report: STRYKER GMBH 40 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number	PIP-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
It was reported the patient fractured their finger, requiring revision surgery.

• Brand Name: 40 SILICONE PIP IMPLANT (STERILE PACKED)
• Common Device Name: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11895880
• Report Number: 0008031020-2021-00246
• Device Sequence Number: 3633096
• Product Code: KYJ
• UDI-Device Identifier: 00886385021577
• UDI-Public: 00886385021577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: PIP-40
• Device Catalogue Number: PIP40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/27/2021
• 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
• Patient Age: 74 YR