MAUDE Adverse Event Report: STRYKER GMBH WRIST FUSION PLATE SHORT BEND VARIAX2 123MM; PLATE, FIXATION, BONE

Model Number	629589
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Burning Sensation (2146); Injury (2348)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device not available for return; consumer retained.
Event or Problem Description
It was reported, patient had left wrist surgery in (b)(6) 2017, he has been experiencing burning.Patient had x-ray that showed broken plate.Revision surgery occurred.
Additional Manufacturer Narrative
Correction.The reported event could be confirmed.The x-rays and operative reports were shared.Therefore, the opinion of stryker's medical expert was requested.The medical statement is the following: "the complaint is clear, the plate broke.The plate was implanted in 2017.The patient went to the surgeon because of complaints in the left wrist.The broken plate was diagnosed in april 2019.After reviewing the available documents a clear root cause cannot be given.The surgeon does describe a non-union in the wrist.This non-union can be the cause of the plate breakage, due to continuous motion in the bones which need to fuse.Or it is the other way around, the plate broke which caused continues motion in the wrist bones, which led to the non-union due to the loss of stability".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 complaint report will be updated.
Event or Problem Description
It was reported, patient had left wrist surgery in (b)(6) 2017, he has been experiencing burning.Patient had x-ray that showed broken plate.Revision surgery occurred.

• Brand Name: WRIST FUSION PLATE SHORT BEND VARIAX2 123MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9965231
• Report Number: 0008031020-2020-01282
• Device Sequence Number: 13573279
• Product Code: HRS
• UDI-Device Identifier: 07613327131444
• UDI-Public: 07613327131444
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 629589
• Device Catalogue Number: 629589
• Device Lot Number: V30574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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 Age: 71 YR
• Patient Weight: 118