MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L34MM; SCREW, FIXATION, BONE

Catalog Number	657434S
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "routine removal of the set screw revealed a thread burr.The primary operation was an ankle fracture which was treated with osteosynthesis implants from stryker (variax t10 screws and a fibula plate distal, lateral).The patient did not suffer any damage as a result of this incident.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Additional Manufacturer Narrative
The received picture was reviewed and it can be confirmed that the thread flanks of the complete screw shaft is peeled off.The anodized layer is not present anymore where the material was peeled off, this is a clear indication that the damage was caused post-manufacturing, most likely by an excessive contact with another device (e.G.Plate or screw).However, without having the device at hand no further evaluation is possible and the exact root cause cannot be defined.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "routine removal of the set screw revealed a thread burr.The primary operation was an ankle fracture which was treated with osteosynthesis implants from stryker (variax t10 screws and a fibula plate distal, lateral).The patient did not suffer any damage as a result of this incident.".

• Brand Name: BONE SCREW VARIAX 2 T10, FULL THREAD, 3.5MM / L34MM
• Common Device Name: SCREW, 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: 18589153
• Report Number: 0008031020-2024-00015
• Device Sequence Number: 7049916
• Product Code: HWC
• UDI-Device Identifier: 07613327074093
• UDI-Public: 07613327074093
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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 Expiration Date: 01/31/2024
• Device Catalogue Number: 657434S
• Device Lot Number: Y60478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• 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 Age: 58 YR
• Patient Sex: Female