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	Foreign Body In Patient (2687)
Date of Event	04/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: "during the execution of a surgical procedure of "fusion of the subtalar", accidentally, at the moment of the introduction of the second fixos screw into the calcaneus, despite the guide wire, the tip of the introducer handpiece broke.Following this event, a small metal splinter remained in the soft tissues that could not be identified and removed.Immediately, an x-ray of the foot was performed which confirmed the presence of the small fragment in the soft tissues.The procedure was completed successfully.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned with a broken tip.The device inspection revealed the following: the tip of the screwdriver was found to be broken.The broken fragment was not returned.The overview of the breakage area indicates a brittle failure of the screwdriver, as evidenced by a smooth and granular surface, as well as the absence of ductile deformation.The breakage has occurred due to the application of excessive torsional forces or bending, resulting in stress concentration and ultimately sudden breakage.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 a user-related issue.The event was caused excessive force and torsional overload applied on the screwdriver, resulting in the tip being broken.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that: "during the execution of a surgical procedure of "fusion of the subtalar", accidentally, at the moment of the introduction of the second fixos screw into the calcaneus, despite the guide wire, the tip of the introducer handpiece broke.Following this event, a small metal splinter remained in the soft tissues that could not be identified and removed.Immediately, an x-ray of the foot was performed which confirmed the presence of the small fragment in the soft tissues.The procedure was completed successfully.".

• 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: 22142532
• Report Number: 0008031020-2025-00942
• Device Sequence Number: 7122607
• Product Code: HWC
• UDI-Device Identifier: 07613252708469
• UDI-Public: (01)07613252708469(10)2321AA
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 07/25/2025

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: 2321AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown