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

Catalog Number PIP50

Device Problems Material Erosion (1214); Material Deformation (2976); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

A silicone pip replacement needed to be replaced because of what looks to be material fatigue.

Event Description

A silicone pip replacement needed to be replaced because of what looks to be material fatigue.

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)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8557907
• MDR Text Key: 143385085
• Report Number: 0008031020-2019-00375
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021591
• UDI-Public: 00886385021591
• 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: 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
• Device Operator: 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 Manufacturer Received: 04/07/2019
• Initial Date FDA Received: 04/26/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention