MAUDE Adverse Event Report: STRYKER GMBH NAIL ADAPTER T2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18063211
Medical Device Problem Code	Mechanical Jam (2983)
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
Correction: please refer to h6 method code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidence 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.

• Brand Name: NAIL ADAPTER T2
• 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: 21437928
• Report Number: 0008031020-2025-00351
• Device Sequence Number: 4528215
• Product Code: LXH
• UDI-Device Identifier: 04546540708489
• UDI-Public: (01)04546540708489(10)K1B269C
• Combination Product (Y/N): N
• Initial Reporter Country: BA
• 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): 06/02/2025

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: 18063211
• Device Lot Number: K1B269C
• 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: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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
• Patient Sex: Unknown