MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X320MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	35251320S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/26/2024
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
The customer reported that: "the patient underwent surgery on (b)(6) 2024 for a gamma nail of the left femur (stryker).Since the afternoon of (b)(6) 2024, she had been experiencing progressive pain in her left hip.On the night of (b)(6) 2024, during a transfer to the toilet, the patient described a rotating movement of the hip with an audible an audible crack.The pain made it impossible to stand on the floor.During surgery on (b)(6) 2024, the femoral nail was found to have ruptured.".
Additional Manufacturer Narrative
Corrected fields: lot number (d4) and product available to stryker (d9).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.There is strong evidence that the wrong lot number was communicated by the user.According to the stryker distribution center in (b)(6), no nails from lot number k198400 were shipped to the hospital in question.Furthermore, these nails were manufactured in 2009 and have been expired since 2014.It is therefore highly unlikely that a nail from this lot was implanted in 2024.It should be noted that implants that have passed their expiration date may undergo a second sterilization (to be carried out exclusively by stryker).However, these implants bear the acronym ¿ra¿ at the end of the original lot number, which is not the case for the lot communicated.Furthermore, lot number k198400 corresponds to the catalog number 32250320s, and not to the catalog number 35251320s, related to the complaint.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that: "the patient underwent surgery on (b)(6) 2024 for a gamma nail of the left femur (stryker).Since the afternoon of (b)(6) 2024, she had been experiencing progressive pain in her left hip.On the night of (b)(6) 2024, during a transfer to the toilet, the patient described a rotating movement of the hip with an audible an audible crack.The pain made it impossible to stand on the floor.During surgery on (b)(6) 2024, the femoral nail was found to have ruptured.".
Event or Problem Description
The customer reported that: "the patient underwent surgery on (b)(6) 2024 for a gamma nail of the left femur (stryker).Since the afternoon of (b)(6) 2024, she had been experiencing progressive pain in her left hip.On the night of (b)(6) 2024, during a transfer to the toilet, the patient described a rotating movement of the hip with an audible an audible crack.The pain made it impossible to stand on the floor.During surgery on (b)(6) 2024, the femoral nail was found to have ruptured.".
Additional Manufacturer Narrative
Please note the correction to d4 and d9.The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned nail was confirmed based on the catalog # and the lot # marked.The implant is broken in two parts, at the level of the lag screw hole.Both parts were returned.The evaluation revealed that the nail broke due to fatigue after 12 weeks of implantation.This can be stated based on the lines of rest clearly visible on the anterior side of the nail, which are a classic indication of a fatigue fracture.According to the observations made, the fatigue fracture had its origination in the lateral side of the anterior portion of the lag screw hole.Material damage, which was caused by misaligned drilling, may have weakened the device and contributed to the breakage.This statement is confirmed by the significant signs of wear (shiny area) on the lateral side of the hole.The removed material created a sharp-edged chamfer.The posterior side of the lag screw hole shows evidence of a sudden "catastrophic" brittle fracture, resulting from the fatigue fracture aforementioned.Material deformation (bearing points) be observed on the edge of the proximal hole, below the lag screw.This indicates that the nail was subjected to severe loads, leading to displacement of the lag screw, associated with the breakage of the nail.This statement is confirmed by the wear marks observed on the returned lag screw.Scratches observed on the exterior of the distal screw holes give evidence of misdrilling when performing the insertion of these screws.Based on investigation, the exact root cause of the implant failure could not be determined.X-ray images as well as the patient medical records would have been necessary for a complete investigation.It must be noted that the misdrilling around the lag screw hole most probably contributed to the fracture, by facilitating and/or accelerating its development.However, it is unlikely to have been the main cause of the breakage.Any manufacturing or design related issue could be ruled out.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.If more information is provided, the case will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 Ø11X320MM 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: 21256688
• Report Number: 0008031020-2025-00223
• Device Sequence Number: 8093185
• Product Code: HSB
• UDI-Device Identifier: 07613252274261
• UDI-Public: (01)07613252274261(17)290131(10)K19B400
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: Lay User/Patient
• Device Catalogue Number: 35251320S
• Device Lot Number: K19B400
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 07/29/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 05/14/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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