MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X280MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34250280S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); Implant Pain (4561)
Date of Event	08/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, when the patient visited the hospital because of the proximal humerus fracture, he also had pain in his femur, where the surgery was performed at another hospital a year and a half ago.Thus, x-ray was taken and it revealed pseudoarticular of the femur and the gamma3 nail fracture at the lag screw hole part.The gamma3 nail will be removed at the same time as the surgery for the proximal humerus fracture on (b)(6) 2024.
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned nail was confirmed based on the catalog # and the lot # marked.The returned implant is broken in two at lag screw hole.Both parts have been returned for inspection.The microscopic inspection revealed that the breakage originated in the lateral side, in the distal portion of the nail.The presence of rest lines gives evidence of a fatigue fracture.Signs of a rapid fracture ("catastrophic rupture") are visible in the distal and in the proximal portions of the nail, giving indication that the implant broke suddenly under high load.The shiny areas observed on the breakage surface are a result of friction between the nail parts during the fracture.These shiny areas are also likely a result of the rapid fracture.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 areas) in the distal side of the lag screw hole, in the inside and in the outside.Damage can 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 could be confirmed based on the marks observed on the lag screw.It was not possible to determine the exact root cause of the breakage.The reported bone nonunion, that could explain the fatigue fracture, could not be confirmed due to the absence of x-rays provided.Patient medical records would also have given essential information, however, this was not provided.It can be stated, based on the extend of the damage observed, that the misaligned drilling had an influence on the fracture, by at least, accelerating its progression.Nonetheless, it is unlikely that the miss-drilling alone caused to the breakage.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 any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported, when the patient visited the hospital because of the proximal humerus fracture, he also had pain in his femur, where the surgery was performed at another hospital a year and a half ago.Thus, x-ray was taken and it revealed pseudoradicular of the femur and the gamma3 nail fracture at the lag screw hole part.The gamma3 nail will be removed at the same time as the surgery for the proximal humerus fracture on (b)(6) 2024.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 Ø10X280MM 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: 20269627
• Report Number: 0009610622-2024-00839
• Device Sequence Number: 3339324
• Product Code: HSB
• UDI-Device Identifier: 04546540375315
• UDI-Public: (01)04546540375315(11)220824(17)270731(10)K0A9C05
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 34250280S
• Device Lot Number: K0A9C05
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female