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	12/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported during a revision surgery that the t30 screwdriver tip was damaged and broke.It was also reported that the patient had very hard bone.A different screwdriver tip was used to complete the surgery and all debris was removed from the surgical field/patient.The tracking number was provided for the product return and no further information was provided regarding the use history of the device.
Additional Manufacturer Narrative
Correction to d4(lot # and gtin), h8(usage of device), and h3(device evaluated by mfg).The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.Tip of the screwdriver found broken.Broken fragment was not returned.Device looks to be intensively used as evidenced by worn out external surface.Microscopic view of the broken surface indicates towards a brittle failure of the screwdriver as evidenced by the chevron lines and fairly smooth surface at the breakage junction.Looking at the fracture lines and nature of the breakage, it is evident that an excess torsional force in clockwise direction has resulted in the breakage of the screwdriver.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 torsional force resulting in brittle failure.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported during a revision surgery that the t30 screwdriver tip was damaged and broke.It was also reported that the patient had very hard bone.A different screwdriver tip was used to complete the surgery and all debris was removed from the surgical field/patient.The tracking number was provided for the product return and no further information was provided regarding the use history of the device.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21217830
• Report Number: 0008031020-2025-00219
• Device Sequence Number: 20992456
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)31564K
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 03/28/2025

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: Lay User/Patient
• Device Catalogue Number: 705212
• Device Lot Number: 31564K
• 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: 12/27/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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: Male