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	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill bit broke off on the side.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction to h3(device evaluated by mfg) the reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.The device inspection revealed the following: in the received screwdriver, just along the d-cut at the adaptor side which gets attached to the handle, a material chip-off was evident.The features observed clearly indicate towards an interaction with a rather sharp object with an impact, causing the material to chip-off from the weaker section.Overall, no other damage could be observed in the device.The drive of the screwdriver was also found in good condition.Since there is just a material chip-off in the non-functional area, the device was found to be functional.However, it is advisable not to use the device in such a state.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is deemed to be user related.The nature of breakage indicates towards an inappropriate interaction of the screwdriver with another object, although maybe unintentional.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the drill bit broke off on the side.

• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22158753
• Report Number: 0008031020-2025-00944
• Device Sequence Number: 15295989
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)0890AA
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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