MAUDE Adverse Event Report: STRYKER GMBH TEMPORARY PLATE FIXATOR AXSOS 3 TI AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	705019
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "during reduction and synthesis of a displaced fracture of the distal tibia and fibula of the left leg, the plate (axsos 3 antero-medial distal tibia) was fixed to the bone with the special "temporary plate fixator" (code 705019).During positioning, the self-drilling tip of the instrument fractured, which remained connected to the lateral cortical bone of the tibia.Given the position and the risk of iatrogenic neurovascular and bone damage related to possible removal, the option was to leave the metal fragment in place.".
Event or Problem Description
As reported: "during reduction and synthesis of a displaced fracture of the distal tibia and fibula of the left leg, the plate (axsos 3 antero-medial distal tibia) was fixed to the bone with the special "temporary plate fixator" (code 705019).During positioning, the self-drilling tip of the instrument fractured, which remained connected to the lateral cortical bone of the tibia.Given the position and the risk of iatrogenic neurovascular and bone damage related to possible removal, the option was to leave the metal fragment in place.".
Additional Manufacturer Narrative
Please note the correction to d9.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences 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.

• Brand Name: TEMPORARY PLATE FIXATOR AXSOS 3 TI AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 23413655
• Report Number: 0008031020-2025-02003
• Device Sequence Number: 18375019
• Product Code: LXH
• UDI-Device Identifier: 07613327093414
• UDI-Public: 07613327093414
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/21/2025

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: 705019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 56 YR
• Patient Sex: Unknown