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

Model Number PIP-40

Device Problem Break (1069)

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

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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.

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 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)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9659480
• MDR Text Key: 189082172
• Report Number: 0008031020-2020-00253
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385021577
• UDI-Public: 00886385021577
• 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: 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
• Device Operator: 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 Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/03/2020
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR