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	09/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported; "during the procedure, the surgeon utilized fixos 7.0 cannulated screws in accordance with the standard surgical technique.While inserting the final screw, the tip of the screwdriver (705212) broke within the screw's drive.It was observed that the patient's bone was harder than usual, necessitating increased force during screw implantation.The procedure proceeded without delay, as a second cannulated screwdriver bit (705212) was available in the surgical tray".
Event or Problem Description
As reported; "during the procedure, the surgeon utilized fixos 7.0 cannulated screws in accordance with the standard surgical technique.While inserting the final screw, the tip of the screwdriver (705212) broke within the screw's drive.It was observed that the patient's bone was harder than usual, necessitating increased force during screw implantation.The procedure proceeded without delay, as a second cannulated screwdriver bit (705212) was available in the surgical tray".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.Tip of screwdriver found broken.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.The internal and external diameter of the screwdriver was found within specification.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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.

• 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: 20467538
• Report Number: 0008031020-2024-00592
• Device Sequence Number: 15291913
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)1667AA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 1667AA
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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 Age: 59 YR
• Patient Sex: Male