MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREWDRIVER FIXOS T30, LARGE AO FITTING; SCREW, FIXATION, BONE

Catalog Number	705212
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the surgeon reports a breakage of the torx 30 screwdriver (cannulated) from the fixos 7.0 mm screw system.Replacement was available.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.Tip of the screwdriver was found broken.Broken fragments were not returned.Two lobes of the torx screwdriver had been found broken.Microscopic view of the broken surface indicates a brittle failure of the screwdriver as evidenced by the fairly smooth surface at the breakage junction.The breakage has occurred due to the application of excessive torsional forces along with bending at the tip of the screwdriver resulting in stress concentration on the edges of the lobes.Also, it could be possible that the tip not seated properly in the screw, or screwdriver used at a slight angle due to which chipping of only few lobes occurred.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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.Based on the investigation, the root cause was attributed to be user related issue.The event is caused by application of excess mechanical forces on the tip of screwdriver resulting in the lobes of the tip being broken.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon reports a breakage of the torx 30 screwdriver (cannulated) from the fixos 7.0 mm screw system.Replacement was available.".

• Brand Name: CANNULATED SCREWDRIVER FIXOS T30, LARGE AO FITTING
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21610366
• Report Number: 0008031020-2025-00417
• Device Sequence Number: 7564979
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)2324AA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K133451
• 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): 06/10/2025

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: 705212
• Device Lot Number: 2324AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown