MAUDE Adverse Event Report: STRYKER GMBH T2 - DRILL, AO D4.2X340 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18064260
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2025
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: "ankle nail was introduced.Screws were locked.Most distal calcaneal screw trajectory was drilled with a 4.2mm drill, trough the targeting device.The drill didn't end up in the hole but scratched the nail on the side.The nail was removed, tested and re-inserted.The incident happened again.This was tried 3 times.Surgery was delayed by 2 hours.A plate was used to fuse the ankle, which lead to extra incision and due to the plate, no bone graft could be used, which was planned.".
Additional Manufacturer Narrative
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 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.
Event or Problem Description
As reported: "ankle nail was introduced.Screws were locked.Most distal calcaneal screw trajectory was drilled with a 4.2mm drill, trough the targeting device.The drill didn't end up in the hole, but scratched the nail on the side.The nail was removed, tested and re-inserted.The incident happened again.This was tried 3 times.Surgery was delayed by 2 hours.A plate was used to fuse the ankle, which lead to extra incision and due to the plate no bone graft could be used, which was planned.".

• Brand Name: T2 - DRILL, AO D4.2X340 MM
• 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; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21966995
• Report Number: 0008031020-2025-00866
• Device Sequence Number: 8492523
• Product Code: LXH
• UDI-Device Identifier: 04546540196767
• UDI-Public: 04546540196767
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 18064260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/09/2025
• 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: Required Intervention
• Patient Sex: Unknown