MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34251380S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: the patient's attorney contacted stryker with the following issue: the patient was operated on at the beginning of (b)(6) 2023 for a fracture of the femoral neck and a gamma nail was inserted.On (b)(6) 2023, the gamma nail broke in the area of the right thigh.The patient subsequently had an inpatient stay from (b)(6) 2023 to (b)(6) 2023.
Additional Manufacturer Narrative
The information in this report was provided by stryker legal affairs department.No additional information is available currently due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report h3 other text : device disposition is unknown.
Additional Manufacturer Narrative
Correction - please refer to h6 results code.The reported event could be confirmed with the provided images.With the available medical notes, a formal medical opinion was sought: with the provided information in the medical notes, it is difficult to determine the cause of the 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.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: the patient's attorney contacted stryker with the following issue: the patient was operated on at the beginning of (b)(6) 2023 for a fracture of the femoral neck and a gamma nail was inserted.On (b)(6) 2023, the gamma nail broke in the area of the right thigh.The patient subsequently had an inpatient stay from (b)(6) 2023 to (b)(6) 2023.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was returned and is awaiting inspection.
Event or Problem Description
As reported: the patient's attorney contacted stryker with the following issue: the patient was operated on at the beginning on (b)(6) 2023 for a fracture of the femoral neck and a gamma nail was inserted.On (b)(6) 2023, the gamma nail broke in the area of the right thigh.The patient subsequently had an inpatient stay from on (b)(6) 2023.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and matches the alleged event.The received nail is broken from the webs of the proximal lag screw hole.Severe drill marks were found at the lateral entrance of the hole majorly along the anterior web on the distal & proximal portion of the nail progressing inward through towards the medial end.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) somewhere at the lateral edge on the anterior web.The breakage pattern resembles breakage in a fatigued manner, evident by visible lines of rest, relatively smooth breakage surface on the initiation side, and abrupt features on the other side.The breakage was initiated in a fatigued manner and broke instantaneously from the other side due to high tension and loading.Signs of heavy overloading were visible on the medial side of the nail which has deformed the nail by bending the material.We can also see misdrilling marks at the distal holes as the material is chipped off at the holes and deforming the material at that end.With the available medical notes, a formal medical opinion was sought: with the provided information in the medical notes, it is difficult to determine the cause of the 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.The operative technique clearly warns the user: in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced which may cause nail to fracture.No indications of material, manufacturing or design related problems were found during the investigation.Based on the above investigation no product related issue could be detected.The implants could finally not resist the applied force which finally led to the material overload/fatigue failure, we can also see misdrilling marks on the broken section of the nails which may have reduced the fatigue strength of the device leading to breakage.However, due to a lack of applicable radiographs, we cannot exactly say what caused this fatigue failure resulting in breakage of the nail.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: the patient's attorney contacted stryker with the following issue: the patient was operated on at the beginning of (b)(6) 2023 for a fracture of the femoral neck and a gamma nail was inserted.On (b)(6) 2023, the gamma nail broke in the area of the right thigh.The patient subsequently had an inpatient stay from (b)(6) 2023.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø11X380MM 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: 18788837
• Report Number: 0009610622-2024-00082
• Device Sequence Number: 7702266
• Product Code: HSB
• UDI-Device Identifier: 07613252273844
• UDI-Public: (01)07613252273844(11)210819(17)260731(10)K0EE1B7
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2024

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 34251380S
• Device Lot Number: K0EE1B7
• 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: 01/30/2024
• Supplement Date Received by Manufacturer: 05/03/2024; 08/27/2024; 10/10/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/23/2024; 09/24/2024; 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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 Age: 86 YR
• Patient Sex: Male
• Patient Weight: 73 KG