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	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "during the surgery which required the use of x1 fixos 7mm cannulated screw, during the final tightening of the screw, the tip of the t30 cannulated screwdriver bit broke into pieces.The remains of the screwdriver bit in the head of the cannulated screw had to be removed by the surgeon.During the procedure, it was very clear that the cannulated screwdriver bit had broken during the final tightening due to sound and movement of the surgeons hand, the surgeon removed the screwdriver from the screw and it was clearly visible that the screwdriver bit had broken.The surgeon seemed okay with the overall result.No further intervention was performed to insert the screw any further as it was the final tightening when the screwdriver bit broke.The surgeon did have to remove the debris that was in the head of the screw." the procedure was delayed by 10-15min.
Additional Manufacturer Narrative
Correction: please refer to section h6 health impact code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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: "during the surgery which required the use of x1 fixos 7mm cannulated screw, during the final tightening of the screw, the tip of the t30 cannulated screwdriver bit broke into pieces.The remains of the screwdriver bit in the head of the cannulated screw had to be removed by the surgeon.During the procedure, it was very clear that the cannulated screwdriver bit had broken during the final tightening due to sound and movement of the surgeons hand, the surgeon removed the screwdriver from the screw and it was clearly visible that the screwdriver bit had broken.The surgeon seemed okay with the overall result.No further intervention was performed to insert the screw any further as it was the final tightening when the screwdriver bit broke.The surgeon did have to remove the debris that was in the head of the screw." the procedure was delayed by 10-15min.
Event or Problem Description
As reported: "during the surgery which required the use of x1 fixos 7mm cannulated screw, during the final tightening of the screw, the tip of the t30 cannulated screwdriver bit broke into pieces.The remains of the screwdriver bit in the head of the cannulated screw had to be removed by the surgeon.During the procedure, it was very clear that the cannulated screwdriver bit had broken during the final tightening due to sound and movement of the surgeons hand, the surgeon removed the screwdriver from the screw and it was clearly visible that the screwdriver bit had broken.The surgeon seemed okay with the overall result.No further intervention was performed to insert the screw any further as it was the final tightening when the screwdriver bit broke.The surgeon did have to remove the debris that was in the head of the screw." the procedure was delayed by 10-15min.
Additional Manufacturer Narrative
Corrections: please refer to section h6 (method and results codes).Pictures of the screwdriver were provided by the reporter.It appears broken at the tip, which is shattered in several debris.Therefore, the event can be confirmed.However, the affected device was not returned and the root cause of this breakage cannot be determined without a deeper device inspection.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.

• 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: 21283998
• Report Number: 0008031020-2025-00230
• Device Sequence Number: 7830409
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)12201D
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K133451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 705212
• Device Lot Number: 12201D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 04/23/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/20/2025; 05/21/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown