MAUDE Adverse Event Report: STRYKER GMBH T2 - TARGETING ARM TNS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18061001
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the instruments, once the patient had already been anesthetized, were found to be defective and unusable.Our agent had to urgently deliver another instrument, which was withdrawn in an emergency from one of our deposit accounts, causing considerable inconvenience to both customers and significantly lengthening the duration of the operation.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Corrections: please refer to d4 (catalog# and gtin).The reported event could not be confirmed since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the targeting arm is in good condition overall and shows no sign of damage, wear or deformation.The targeting arm and nail handle could be assembled as intended without any difficulty.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the instruments, once the patient had already been anesthetized, were found to be defective and unusable.Our agent had to urgently deliver another instrument, which was withdrawn in an emergency from one of our deposit accounts, causing considerable inconvenience to both customers and significantly lengthening the duration of the operation.".

• Brand Name: T2 - TARGETING ARM TNS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22064403
• Report Number: 0008031020-2025-00909
• Device Sequence Number: 18095831
• Product Code: LXH
• UDI-Device Identifier: 04546540196521
• UDI-Public: 04546540196521
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/15/2025

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: 18061001
• Device Lot Number: KHI023693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2003
• 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