MAUDE Adverse Event Report: STRYKER GMBH ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø11X200MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18191120S
Medical Device Problem Code	Positioning Failure (1158)
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.".
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
Correction: please refer to section d9 the device was returned.The reported event could be confirmed since the misdrilling marks are visible on the nail.The device inspection revealed the following: only the ankle nail and one screw was received for evaluation.Other components such as drill, sleeves, target device were not received for analysis.Ankle nail is damaged near the distal holes.There is strong contact most probably with the drill during drilling operation as stated in the event description as well.Notably both the circular distal hole is having this kind of damage.The received screw is showing marks of usage both in the head and the tip region as indicated by the damaged coating.It looks like an attempt was made to tighten the screw but due to misdrilling the screw insertion did not took place.A functional inspection was done using sample drill, drill sleeve, tissue protection sleeve, target device and returned screw and nail, it was confirmed that the drill and screw is easily passing through the distal holes of the nail which contradicts the alleged failure.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.Based on the investigation, the root cause was attributed to a usage related issue since the nail does not contribute towards alleged failure.If more information is provided, the case will be reassessed.

• Brand Name: ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø11X200MM
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21966793
• Report Number: 0008031020-2025-00863
• Device Sequence Number: 12849736
• Product Code: HSB
• UDI-Device Identifier: 04546540673411
• UDI-Public: (01)04546540673411(11)241118(17)291031(10)K1E6589
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051590
• 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): 11/18/2025

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: 18191120S
• Device Lot Number: K1E6589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown