MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "breakage of the "gamma nail 11x340" with 85 shank screw inserted on (b)(6)2020.A revision surgery was performed.".
Additional Manufacturer Narrative
Please note correction to d9/h3 as the device was returned for evalaution.Please also note the corrections to h6 method, h6 results and h6 conclusion codes.The reported event could be confirmed, since the nail is broken apart as complained.The device inspection revealed the following: the visual inspection has shown the nail is broken apart at the lag screw hole.During the microscopic inspection the typical characteristics of a fatigue fracture could be identified on both fracture faces.The origin of the crack was at the lower corners of the bore, there is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture.At the the proximal fragment of the nail are very strong impression marks from the lag screw in the bore visible, which indicates that the nail was exposed to high loads over a long period of time.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 factor related issue.The breakage of the device after 22 months of implantation, is most likely to be caused due to overloading of the device over a long period of time.Presence of signs of a fatigue fracture and absence of any remarkable user induced damage to the device supports this cause.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 more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "breakage of the "gamma nail 11x340" with 85 shank screw inserted on (b)(6) 2020.A revision surgery was performed.".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X340MM 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: 14830698
• Report Number: 0009610622-2022-00310
• Device Sequence Number: 2367782
• Product Code: HSB
• UDI-Device Identifier: 07613252273820
• UDI-Public: 07613252273820
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 12/31/2024
• Device Model Number: 3425-1340S
• Device Catalogue Number: 34251340S
• Device Lot Number: K0D8584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• 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: 53 YR
• Patient Sex: Female