MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, RIGHT,LONG, 14 HOLES; PLATE, FIXATION, BONE

Model Number	54-25387
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	11/28/2019
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, the plate broke after 2 months.Revision surgery needed.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned volar smartlock distal radius plate is completely broken off.It was visible that the plate is actually slightly bent and twisted, which indicates that possibly too much weight had been applied (despite the given information that the patient followed the instructions).Especially as it was also mentioned ¿macroscopically normal bone consistency, no signs of osteoporosis¿.Also there are some marks on the plate which might have been caused during the revision.The close up pictures, performed by the microscope, of the fractured plate indicate a fatigue fracture as a shiny surface is evident (wear).The rest of the broken surface is homogenous though.So we can state that the breakage started on the right hand side of the plate.The rest of the broken surface is homogenous though which indicates conformity to the given specification.A review of the device history for the reported lot did not indicate any abnormalities.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.Based on investigation, the root cause was attributed to be patient related.The failure was caused by possibly too much weight which had been applied.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported, the plate broke after 2 months.Revision surgery needed.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, STANDARD, RIGHT,LONG, 14 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9527644
• Report Number: 0008031020-2019-02516
• Device Sequence Number: 2777536
• Product Code: HRS
• UDI-Device Identifier: 07613154345533
• UDI-Public: 07613154345533
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 54-25387
• Device Catalogue Number: 54-25387
• Device Lot Number: 1000337430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/14/2020
• 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 Weight: 90