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 Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient's hand (knuckle) was revised due to the pip silicone implant breaking.A 40 silicone pip implant was revised to another 40 silicone pip implant.
Additional Manufacturer Narrative
The reported event could only partially be confirmed, since the device was returned, but no x-rays were provided.More detailed information about the complaint event (x-rays, operative surgery.) must be available in order to determine the root cause of the complaint event.The device inspection revealed the following: the product was returned and shows severe signs of wear (multiple scratches are noticed).Moreover, the implant is partially cut in two.Unfortunately, the analysis of the returned device alone is not sufficient to allow us to draw conclusions on this case.A review of the device history was not possible because the lot number 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 any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that the patient's hand (knuckle) was revised due to the pip silicone implant breaking.A 40 silicone pip implant was revised to another 40 silicone pip implant.

• 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 ; CH 2545
• MDR Report Key: 9659480
• Report Number: 0008031020-2020-00253
• Device Sequence Number: 19670656
• Product Code: KYJ
• UDI-Device Identifier: 00886385021577
• UDI-Public: 00886385021577
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K931588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: PIP-40
• Device Catalogue Number: PIP40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: 72 YR