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

Catalog Number	705212
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the cannulated driver broke on the threading and the patient had to be opened up to find the broken piece.The procedure time was extended and completed using a second cannulated driver, on power and by hand, switching it back and forth.The surgeon had to open the patient up a bit further to find the missing piece that was stuck on the guide wire, and the surgery went a bit longer than anticipated.Otherwise, no further complications were experienced.All debris was removed.
Event or Problem Description
It was reported that the cannulated driver broke on the threading and the patient had to be opened up to find the broken piece.The procedure time was extended and completed using a second cannulated driver, on power and by hand, switching it back and forth.The surgeon had to open the patient up a bit further to find the missing piece that was stuck on the guide wire, and the surgery went a bit longer than anticipated.Otherwise, no further complications were experienced.All debris was removed.
Additional Manufacturer Narrative
Correction to d9(product available to stryker) and 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: the received screwdriver showed normal signs of usage.However, the tip region was found to be broken and the fracture pattern was oblique.The fracture surface majorly exhibited typical characteristics of a brittle failure and very minimal signs of a ductile fracture, evident by largely a smooth fracture surface with slight plastic deformation.The broken tip showed similar features but also carried an additional crack which is also indicative of high loading, most likely combination of torsional & bending load.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 usage of the screwdriver evident by predominantly a brittle fracture and oblique fracture pattern indicating towards application of excessive bending & torsional load.The ifu warns the user that: while rare, intra-operative fracture or breakage of instruments can occur.Instruments which have experienced excessive use or excessive force are susceptible to fracture.Instruments should be examined for wear or damage prior to surgery.If any additional information is provided, the investigation will be reassessed.

• 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: 23596413
• Report Number: 0008031020-2025-02085
• Device Sequence Number: 10291708
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)2324AA
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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 Catalogue Number: 705212
• Device Lot Number: 2324AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 03/06/2026
• 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