MAUDE Adverse Event Report: STRYKER GMBH T2 ANKLE - ANKLE ARTHRODESIS NAIL, LEFT D12X200MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18181220S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the end user has reported that an issue has occurred during the t2 ankle fusion surgery performed.After successfully placing the dynamic compression screws and proximal static screws, they encountered a problem while attempting to place the posterior calcaneus screws.The drill was unable to pass through the nail and instead hit the nail, not going through the dedicated hole as intended.The surgeon was unable to generate proper compression to enhance the fusion procedure, which significantly impacted the outcome of the surgery.Due to the defect, the surgeon had to freehandedly insert the screw, which caused a significant delay and inconvenience, affecting the overall operating time".
Event or Problem Description
As reported: "the end user has reported that an issue has occurred during the t2 ankle fusion surgery performed.After successfully placing the dynamic compression screws and proximal static screws, they encountered a problem while attempting to place the posterior calcaneus screws.The drill was unable to pass through the nail and instead hit the nail, not going through the dedicated hole as intended.The surgeon was unable to generate proper compression to enhance the fusion procedure, which significantly impacted the outcome of the surgery.Due to the defect, the surgeon had to freehandedly insert the screw, which caused a significant delay and inconvenience, affecting the overall operating time".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was 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.

• Brand Name: T2 ANKLE - ANKLE ARTHRODESIS NAIL, LEFT D12X200MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 21437927
• Report Number: 0008031020-2025-00350
• Device Sequence Number: 4528214
• Product Code: HSB
• UDI-Device Identifier: 04546540673350
• UDI-Public: 04546540673350
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• PMA/510(K) Number: K051590
• 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): 05/29/2025

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: 18181220S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown