MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, RIGHT GAMMA4 Ø10X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84250320S
Medical Device Problem Codes	Positioning Failure (1158); Malposition of Device (2616)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "opened the right nail of gamma 4 diameter 10mm / length 320mm.Lug screw interference check was performed.After inserting the nail and lag screw, the distal device was attached, and after adjusting the height, the most distal circular hole was drilled, but after passing through the front hole, the drill did not pass through due to interference inside the nail.After that, we tried the distal most round hole and the elliptical hole, but the drills did not pass through all of them.When the c-arm was inserted from right beside the distal end of the nail to switch to radiolucent, it was discovered that the cut surface at the distal end of the nail was not forward, but backward.After removing the nail, a nail one size shorter (300 mm) was reinserted.Surgery was completed.After surgery, the distal device and nail were installed and calibrated, and the drill did not pass".
Additional Manufacturer Narrative
Correction b1, g1contact, given the limited information available at the time the complaint was received, the case was initially assessed as "reportable ¿ serious injury." however, the additional information provided by the reporter, along with a review of the case by our medical expert, confirmed that the case does not meet the criteria for a serious injury.A review of the complaint history indicates that there have been no reports of death or serious injury resulting from similar events involving this device or similar device.Additionally, the review of the risk documentation does not suggest that a recurrence of this event would result in death or serious injury.As a result, the reportability assessment has been downgraded from ¿reportable ¿ serious injury¿ to ¿not reportable.¿.
Event or Problem Description
As reported: "opened the right nail of gamma 4 diameter 10mm / length 320mm.Lug screw interference check was performed.After inserting the nail and lag screw, the distal device was attached, and after adjusting the height, the most distal circular hole was drilled, but after passing through the front hole, the drill did not pass through due to interference inside the nail.After that, we tried the distal most round hole and the elliptical hole, but the drills did not pass through all of them.When the c-arm was inserted from right beside the distal end of the nail to switch to radiolucent, it was discovered that the cut surface at the distal end of the nail was not forward, but backward.After removing the nail, a nail one size shorter (300 mm) was reinserted.Surgery was completed.After surgery, the distal device and nail were installed and calibrated, and the drill did not pass".

• Brand Name: LONG NAIL, RIGHT GAMMA4 Ø10X320MM X 125°
• 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: 21659994
• Report Number: 0008031020-2025-00433
• Device Sequence Number: 8272521
• Product Code: HSB
• UDI-Device Identifier: 07613327479515
• UDI-Public: 07613327479515
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: 84250320S
• Device Lot Number: K1BC9B7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 40 KG