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

Catalog Number	54-25374S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "abrasion on variax during medical procedure when mounting screw on it.The procedure was delayed by 10 min.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "abrasion on variax during medical procedure when mounting screw on it.The procedure was delayed by 10 min.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches alleged failure.The received volar smartlock distal radius plate was visually inspected in which we can see a lot of scratch marks and screw rubbing-off marks on the screw holes which indicate usage and application of force while screw tightening.On the oblong hole, we can clearly see a misalignment while insertion as the screw has hit the plate and deformed it.The deformation indicates the screw rubbed off with the plate when it was inserted into an oblong hole.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.Based on the investigation, the root cause was attributed to user related as we can see signs of misdrilling.If any further information is provided, the investigation report will be reassessed.

• Brand Name: VOLAR SMARTLOCK DISTAL RADIUS PLATE, NARROW, LEFT,SHORT, 9 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18073290
• Report Number: 0008031020-2023-00384
• Device Sequence Number: 20787378
• Product Code: HRS
• UDI-Device Identifier: 04546540578679
• UDI-Public: 04546540578679
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 54-25374S
• Device Lot Number: 1000512140
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• 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
• Patient Sex: Unknown