MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW, FULLY THREADED T2 Ø5X45 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965045S
Medical Device Problem Codes	Break (1069); Fracture (1260)
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) 2023.04.22.2024 - update: "additionally a broken locking screw was reported.".
Additional Manufacturer Narrative
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 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.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.H3 other text: device disposition is unknown.
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) 2023.04.22.2024 - update: "additionally, a broken locking screw was reported".
Additional Manufacturer Narrative
Corrections: please refer to d9/h3 the device was returned for evaluation.The reported event could be confirmed, since the device was returned and matches the alleged event.The received screw was visually inspected in which we can see that the screw is broken from the distal end.The deformation of the crest of screw threads indicates that they rub around the nail.This is from improper alignment of the threads which is confirmed from misdrilling signs on the distal holes of the nail.Microscopic inspection of the broken surface of the screw it shows typical signs of breakage in a fatigue manner.The typical characteristics of a fatigue fracture could also be identified on this fracture face.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface which ends in an instantaneous zone, where the screw finally breaks apart.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.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.However, due to a lack of applicable radiographs, we cannot exactly say what caused this fatigue failure resulting in alleged event.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 Ø5X45 MM
• 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: 19341456
• Report Number: 0009610622-2024-00193
• Device Sequence Number: 7142962
• Product Code: HSB
• UDI-Device Identifier: 04546540202505
• UDI-Public: (01)04546540202505(17)280229(10)K1250C0
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K203819
• 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
• Report Date (Section B): 12/03/2024

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 Catalogue Number: 18965045S
• Device Lot Number: K1250C0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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