MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3225-0380S
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	05/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a broken gamma3 nail (3525-0360s)."the patient was treated externally for a per/subtrochanteric left femur fracture on (b)(6) 2021 with a gamma nail.During the consultation (b)(6) 2022, the implant fracture was diagnosed and the patient was admitted to hip clinic at balgrist university hospital for further treatment.Here the indication for revision was given in case of symptomatic pseudarthrosis.If the bone failed to heal and the implant fractured, the indication for revision was given.The indication for revision was given and the patient had to undergo surgery on (b)(6) 2022.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported a broken gamma3 nail (3525-0360s)."the patient was treated externally for a per/subtrochanteric left femur fracture on (b)(6) 2021 with a gamma nail.During the consultation (b)(6) 2022, the implant fracture was diagnosed and the patient was admitted to hip clinic at balgrist university hospital for further treatment.Here the indication for revision was given in case of symptomatic pseudarthrosis.If the bone failed to heal and the implant fractured, the indication for revision was given.The indication for revision was given and the patient had to undergo surgery on (b)(6) 2022.".
Additional Manufacturer Narrative
Please note corrections to sections d1, d4 catalog #, gtin and g4 510(k) number.The reported event could be confirmed, since the received nail is broken apart as complained.The device inspection revealed the following: the visual inspection has shown that the nail is broken apart at the lag screw hole.There are strong impression marks from the lag screw in the lag bore visible, which indicates that the nail was exposed to high loads over a longer period of time.Also are some slight marks from intra-operative reaming visible on the whole surface, there is no indication that these marks did contribute to the breakage.The typical characteristics of a fatigue fracture could be identified on both fracture faces.The origin of the crack was at the lower corners at the lag screw entry point, there is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.The relevant dimensions were verified during the investigation and no deviation from the specification could be detected.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 investigation, the root cause was attributed to a patient related issue.The reported pseudarthrosis did finally lead to a fatigue failure of the implants.In this relation following statement from the instructions for use can be mentioned: ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.".If updated information is provided, the case will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X380MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15112656
• Report Number: 0009610622-2022-00342
• Device Sequence Number: 5978284
• Product Code: HSB
• UDI-Device Identifier: 04546540375759
• UDI-Public: 04546540375759
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 09/30/2023
• Device Model Number: 3225-0380S
• Device Catalogue Number: 35250380S
• Device Lot Number: K072D01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2018
• 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: Female