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	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the surgeon that a torx 30 screwdriver (cannulated), from the fixos 7.0 mm screw system broke intraoperatively.Another screw driver was taken from the op tray.The article is 2 months old and it has been sterilized 3 times.There was no debris reported.
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.
Additional Manufacturer Narrative
Correction to d9(product available to stryker).The reported event could not be confirmed since the device was not returned and no other evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned, and no other evidence was provided for evaluation.The batch record could not be reviewed because the affected device was not returned, and the lot number communicated was incorrect.No corrective actions are required at this time.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root case of the issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the surgeon that a torx 30 screwdriver (cannulated), from the fixos 7.0 mm screw system broke intraoperatively.Another screwdriver was taken from the op tray.The article is 2 months old and it has been sterilized 3 times.There was no debris reported.
Additional Manufacturer Narrative
Correction to d9(product available to stryker), h3(device evaluated by mfg), and h6( method code, results code, conclusion code).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 evident by appearance of minor scratch marks.However, the tip region was found to be broken, and the fracture pattern was largely oblique and uneven.The fracture surface exhibited mixed characteristics of a brittle & ductile failure, but predominantly a brittle one due excessive torsional & bending loading.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 a largely brittle fracture indicating towards application of excessive bending & torsional loading.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the surgeon that a torx 30 screwdriver (cannulated), from the fixos 7.0 mm screw system broke intraoperatively.Another screw driver was taken from the op tray.The article is 2 months old and it has been sterilized 3 times.There was no debris reported.

• 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: 22479169
• Report Number: 0008031020-2025-01077
• Device Sequence Number: 20818950
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)2640AB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: 2640AB
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 09/25/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/11/2025; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2024
• 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