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 Code	Failure of Implant (1924)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "there is a break in an implanted wrist fusion plate.Original implant date (b)(6) 2022.Unsure of the exact day of the break.Revision took place on (b)(6) 2022.The patient was casted the entire time post the primary surgery.Reason for initial implantation: unknown.Screws came out and fusion plate was removed, no debris.Screws are unavailable for return, plate will be the only component returned.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the plate is broken apart as complained.The device inspection revealed the following: the visual inspection has shown that the plate is broken apart at the transverse oblong hole.There are scratches all over the plate, afterwards it cannot be defined if these damages were caused during insertion or extraction.The microscopic examination of the fracture surface reveals the fracture to be a typical fatigue fracture evident by a smooth topography.There are shiny surfaces on both fracture faces, also is there a shiny surface in the area where the screw head was places, which indicates that the fragments rubbed against each other and the screw after the breakage.The rest of the fracture face has the typical view of a fatigue fracture with an uniform fine-grained texture.There are in the oblong hole strong damages from the screw insertion visible, it looks like the screw was screwed in at a very slanted angle.Afterwards it cannot be defined if these damages did contribute to the failure of the plate.The relevant dimensions were as far as possible verified during the investigation and no deviation from the specification could be detected.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.The broken plate was returned for evaluation and no product related issue could be detected.There was no additional information about the event provided, neither x-rays or operation report was available.Therefore the root cause of the breakage cannot be defined.The evaluation of the plate has shown that fatigue did lead to the breakage of the device.
Event or Problem Description
As reported: "there is a break in an implanted wrist fusion plate.Original implant date (b)(6)2022.Unsure of the exact day of the break.Revision took place on (b)(6)2022.The patient was casted the entire time post the primary surgery.Reason for initial implantation: unknown screws came out and fusion plate was removed no debris screws are unavailable for return, plate will be the only component returned.".

• 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: 15982713
• Report Number: 0008031020-2022-00674
• Device Sequence Number: 5884004
• Product Code: HRS
• UDI-Device Identifier: 07613327131444
• UDI-Public: 07613327131444
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: K31083
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 69 YR
• Patient Sex: Male