MAUDE Adverse Event Report: STRYKER GMBH 50 SILICONE PIP IMPLANT (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number	PIP50
Medical Device Problem Codes	Material Erosion (1214); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
A silicone pip replacement needed to be replaced because of what looks to be material fatigue.
Event or Problem Description
A silicone pip replacement needed to be replaced because of what looks to be material fatigue.
Additional Manufacturer Narrative
The reported event could only partially be confirmed, since the device was returned, but no x-rays were provided.More information such as when the device was implanted, the patient's data and activity level, x-rays.Etc, are needed in order to determine the exact root cause of the complaint.The device inspection revealed the following: the product was returned and shows slight signs of wear such as deformed edges of the material, and loss of material in some areas.However, the device is not cut in two.Unfortunately, the analysis of the returned device alone is not sufficient 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.

• Brand Name: 50 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: 8557907
• Report Number: 0008031020-2019-00375
• Device Sequence Number: 2192023
• Product Code: KYJ
• UDI-Device Identifier: 00886385021591
• UDI-Public: 00886385021591
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K931588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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 Catalogue Number: PIP50
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 04/07/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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