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

Catalog Number 54-25374S

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

As reported: "abrasion on variax during medical procedure when mounting screw on it.The procedure was delayed by 10 min.".

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "abrasion on variax during medical procedure when mounting screw on it.The procedure was delayed by 10 min.".

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
• Type of Device: 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
• MDR Text Key: 327400703
• Report Number: 0008031020-2023-00384
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 04546540578679
• UDI-Public: 04546540578679
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1