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	03/25/2025
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.Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
As reported: "the surgeon was implanting cannulated screws for and ankle fusion.He was implanting them by hand into the patient over the 3.2mm guide wire.The tip of the driver broke off in the t30 star drive recess for the screw.The fragment became stuck in the screw head.Using kelly clamps, he was able to pull the broken pieces of the driver tip out.We then explanted the screw to examine if the screw had become damaged or had any piece of the driver left in it, we were able to remove the fragmented driver tip from the patient and patient will be fine.This increased operative time as we had to search for and remove the broken piece of the driver.".
Additional Manufacturer Narrative
The reported event could be confirmed, since pictures of the device were provided: the tip of the screwdriver has broken and is separated from the shaft.However, the root cause of this breakage cannot be determined solely based on these images.Detailed views of the fracture face as well as a proper device inspection would have been necessary.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon was implanting cannulated screws for and ankle fusion.He was implanting them by hand into the patient over the 3.2mm guide wire.The tip of the driver broke off in the t30 star drive recess for the screw.The fragment became stuck in the screw head.Using kelly clamps, he was able to pull the broken pieces of the driver tip out.We then explanted the screw to examine if the screw had become damaged or had any piece of the driver left in it.We were able to remove the fragmented driver tip from the patient and patient will be fine.This increased operative time as we had to search for and remove the broken piece of the driver.".

• 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: 21876474
• Report Number: 0008031020-2025-00736
• Device Sequence Number: 12713581
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)12200D
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/17/2025

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: 12200D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2019
• 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