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

Catalog Number	629589
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/05/2019
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
Customer reported that a variax wrist fusion plate has broken and will be removed on (b)(6).
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the failure mode.Based on the investigation, the root cause was attributed to be patient related.The failure was caused by overloading of the plate due to non-union of the bone.Device inspection revealed the following: the plate is broken in two pieces, both pieces have been received for evaluation.The surface of the plate is scratched with a few dents - most likely caused during contouring, implantation and/or extraction procedure, while the holes of the plate have deformed threads.All the broken surfaces present a polished area and indicates that the fracture started at the top edge and progressed across the shaft until the remaining material was no longer strong enough to support the load and it finally broke.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.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer reported that a variax wrist fusion plate has broken and will be removed on (b)(6).

• 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: 8392630
• Report Number: 0008031020-2019-00144
• Device Sequence Number: 2926618
• Product Code: HRS
• UDI-Device Identifier: 07613327131444
• UDI-Public: 07613327131444
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K151178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 629589
• Device Lot Number: Y03763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 0
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR