MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0400S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.H3 other text : the consumer retained the device.
Event or Problem Description
It was reported that: "patient with a gamma3 nail broke inside patient.Installed on (b)(6) 2023 and subsequently broke (date unknown but probably a few days before (b)(6) 2023).Apparently patient was told they could walk soon/some time after surgery.Broken nail removed and replaced with another gamma3 nail on (b)(6) 2023.".
Additional Manufacturer Narrative
Correction - please refer to d3.The reported event could be confirmed, from the available pictures and radiographs.From the available images, we can confirm that the nail is broken in the webs of the proximal lag screw hole but a further device is required to analyze the breakage surface.From the available radiographs, a formal medical opinion was sought: ¿the fracture is a very unstable reverse trochanteric fracture and these particular fractures need proper reduction and (often) additional stability, and depending on the patient and activity even restrictions in the post-operative care regime.Not much clinical information is provided, but based on the x-rays, we can judge that a long gamma nail broke approximately 3 months after the initial surgery for this particular unstable fracture type.The limited x-rays provided show that the fracture was only stabilized with the long gamma nail.This implant alone may not have been sufficient to bear to loads on the fixed fracture, which results in an inadequate biomechanical distribution of the loads on the implant, leading it to break, most probably in fatigue manner.Furthermore, after three months, there are little signs of healing (bone formation) of the fracture on the available x-ray.The fracture tends to become a non-union, probably related to a lack of stability around the fracture area and too much movement.This combination of events led to the implant breaking.¿ 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 investigation, the root cause of the reported event is multi-factorial: the location of the fracture, the choice of the implant given the fracture type, and the patient activity levels post-op may have contributed to an inadequate load distribution, and therefore the breakage of the implant.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that: "patient with a gamma3 nail broke inside patient.Installed on (b)(6) 2023 and subsequently broke (date unknown but probably a few days before (b)(6) 2023).Apparently patient was told they could walk soon/some time after surgery.Broken nail removed and replaced with another gamma3 nail on (b)(6) 2023.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X400MM 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: 16953259
• Report Number: 0009610622-2023-00158
• Device Sequence Number: 3340055
• Product Code: HSB
• UDI-Device Identifier: 04546540375766
• UDI-Public: 04546540375766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K034002
• 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): 08/09/2023

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 Model Number: 3525-0400S
• Device Catalogue Number: 35250400S
• Device Lot Number: K08C2AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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: 76 YR
• Patient Sex: Male