MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251360S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "during osteosynthesis surgery for subtrochanteric fracture of the femur, a gamma 3 cephalomedullary nail is used, which at the time of inserting the grub screw, is welded to the inside of the implant, preventing the proper blocking of the sliding screw".
Event or Problem Description
As reported: "during osteosynthesis surgery for subtrochanteric fracture of the femur, a gamma 3 cephalomedullary nail is used, which at the time of inserting the grub screw, is welded to the inside of the implant, preventing the proper blocking of the sliding screw.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the set screw is stuck and could not be removed during the investigation.The device inspection revealed the following: the complete nail was returned for evaluation.The tip of the set screw is visible in the lag screw hole.It is obvious that the screw protrudes far too much, much further than necessary to fix the set screw.The anodized layer at the forefront of the set screw and as well the layer in the lag screw hole are intact, there are no wear marks from the lag screw insertion visible.The visual inspection has shown that there are very strong reaming marks at the nail outside, lateral from the lag screw hole, visible.The reaming marks have the same angulation as the lag screw would have.These marks indicate that the lag screw was most likely placed next to the hole instead of in the hole.This explains why the set screw was turned in too much, without the lag screw the screw was turned till to the end point of the thread.Reaching the end point did lead to the impression that the lag screw should be fixated, but the lag screw was still movable which did lead to an over-tightening of the set screw as the tightening finally had no effect on the lag screw.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 investigation, the root cause was attributed to a user related issue.The event was caused by an incorrectly placed lag screw, which did lead to an over-tightening of the set screw.If more information is provided, the case will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X360MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18387610
• Report Number: 0009610622-2023-00464
• Device Sequence Number: 2772837
• Product Code: HSB
• UDI-Device Identifier: 07613252274285
• UDI-Public: 07613252274285
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K200869
• 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): 04/03/2024

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: 35251360S
• Device Lot Number: K0C6919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 81 KG