MAUDE Adverse Event Report: STRYKER GMBH WRIST FUSION PLATE SHORT BEND VARIAX 2 WRIST FUSION 123MM; PLATE, FIXATION, BONE

Model Number	629589
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device is unavailable; hospital retained.
Event or Problem Description
It was reported that a wrist fusion plate had broken.The patient had come in and reported that his wrist hurt, and so the plate and nine screw were removed and replaced with a competitor device.
Event or Problem Description
It was reported that a wrist fusion plate had broken.The patient had come in and reported that his wrist hurt, and so the plate and nine screw were removed and replaced with a competitor device.
Additional Manufacturer Narrative
Please note the corrections to d9/h3 and h6 method, h6 results and h6 conclusion codes as the device was returned for evaluation.The reported event could be confirmed, since the received plate is broken as complained.The visual inspection of the screws and plate returned showed that the plate was indeed broken in two parts on the 6th hole from the distal part and that the 8 returned locking screws are intact and therefore concomitant.The identification of the device is confirmed based on the lot number and the catalog number marked.Signs of a fatigue fracture are visible with the microscopic analysis of the broken area, such as a fracture surface that is shiny and abraded.This is a result of the fragments (opposing bridges of the plate) rubbing against each for an extended period of time, before completely breaking due to fatigue and overloading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a patient related issue.The failure was probably caused by repeated overloading of the plate.If any additional information is provided, the investigation will be reassessed.

• Brand Name: WRIST FUSION PLATE SHORT BEND VARIAX 2 WRIST FUSION 123MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14356972
• Report Number: 0008031020-2022-00229
• Device Sequence Number: 19853031
• Product Code: HRS
• UDI-Device Identifier: 07613327131444
• UDI-Public: 07613327131444
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K151178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: 629589
• Device Catalogue Number: 629589
• Device Lot Number: Y39529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male