MAUDE Adverse Event Report: STRYKER GMBH VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES; PLATE, FIXATION, BONE

Model Number	54-25384
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/08/2020
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
The customer reported that the variax distal radius plate broke and requires future revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the plate is broken at the level of the most distal hole of the shaft.The microscope analysis shows a shiny surface on the medial bridges of the plate.A crack most probably initiated medially before propagating to the lateral side and had the plate brake completely.In parallel, the two sides of the bridge where the breakage started rubbed against each other creating this shiny surface.The above findings suggest the breakage to be a fatigue fracture.Therefore, based on the device inspection, material fatigue is the most probable cause for the breakage.Based on the above and due to limited information provided the root cause for the breakage cannot be determined.More information such as x-rays, patient data and medical records are necessary to give a clear statement regarding the root cause.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The customer reported that the variax distal radius plate broke and requires future revision surgery.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, RIGHT,SHORT, 9 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9672356
• Report Number: 0008031020-2020-00291
• Device Sequence Number: 2923115
• Product Code: HRS
• UDI-Device Identifier: 07613154345502
• UDI-Public: 07613154345502
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K040022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 54-25384
• Device Catalogue Number: 54-25384
• Device Lot Number: 1000250591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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