MAUDE Adverse Event Report: STRYKER GMBH VOLAR DR PLATE INTERM. RIGHT EXTRASHORT; PLATE, FIXATION, BONE

Catalog Number	54-25683S
Medical Device Problem Codes	Material Fragmentation (1261); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A variax2 distal radius plate, a hole in the plate was observed while performing the surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction - d4 - lot #, h6 - device code grid.The reported event that could not be confirmed since the reported incident was not observed.The device inspection revealed the following: the device identification was confirmed based on the catalog # and lot # marked.Dirt debris could be seen on one of the plate holes, but it could be easily removed.The reported piece of titanium closing the hole was not observed, it could have been mistaken for the dirt mentioned.There is stain around the hole in question, however, it was not possible to determine its origin.It was not possible to determine the origin of the debris nor of the stain.It was not possible to determine when and how they appeared.The root cause of the reported event could not be identified.Nonetheless, it could be excluded that the debris is titanium and that it closed the plate hole, as described in the complaint.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 additional information is provided, the investigation will be reassessed.
Event or Problem Description
A variax2 distal radius plate, a hole in the plate was observed while performing the surgery.

• Brand Name: VOLAR DR PLATE INTERM. RIGHT EXTRASHORT
• 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: 19606775
• Report Number: 0008031020-2024-00251
• Device Sequence Number: 6359622
• Product Code: HRS
• UDI-Device Identifier: 07613252614517
• UDI-Public: 07613252614517
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K133974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 54-25683S
• Device Lot Number: 1000550295
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2024
• 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