MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, RIGHT GAMMA4 Ø10X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	84250340S
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that: "the surgery was performed to implant the t2 alpha nail for a patient with right subtrochanteric fracture.When the precision pin was inserted, it interfered with the nail.After that, the nail passed through, but the lag screw reamer did not.The surgery was completed after replacing the precision pin with another one and replacing the nail with 360 mm nail because they were damaged.".
Additional Manufacturer Narrative
Corrected field: component code grid (h6).The reported event could be confirmed since the device was returned for evaluation and the damage on nail indicate the alleged event.The returned device was visually inspected, and we saw reamer marks on the proximal hole of the nail, which indicate that the reamer contacted the nail during the reaming process.This was also confirmed on the reamer, as we can see the contact marks on the cutting flutes.A functional inspection was conducted with the returned nail, reamer, and sample targeting device and sleeve, in which we found no misdrilling; the reamer can be moved easily within the proximal hole with a gap from the walls.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 is user related as the functional inspection of nail and reamer indicate they are functional in nature, so this confirms that the event is not related to them.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that: "the surgery was performed to implant the t2 alpha nail for a patient with right subtrochanteric fracture.When the precision pin was inserted, it interfered with the nail.After that, the nail passed through, but the lag screw reamer did not.The surgery was completed after replacing the precision pin with another one and replacing the nail with 360 mm nail because they were damaged.".

• Brand Name: LONG NAIL, RIGHT GAMMA4 Ø10X340MM 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: 21692893
• Report Number: 0008031020-2025-00437
• Device Sequence Number: 8849870
• Product Code: HSB
• UDI-Device Identifier: 07613327479409
• UDI-Public: (01)07613327479409(17)340131(10)K1A3877
• 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): 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: 84250340S
• Device Lot Number: K1A3877
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• 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
• Patient Age: 61 YR
• Patient Sex: Male