MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0360S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "postoperatively gamma3 long nail was broken and a revision surgery was performed.The broken part is the lag screw hole.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
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 that the nail is broken apart at the lag screw hole.Under the microscope the typical characteristics of a fatigue fracture could be identified on both fracture faces.There is a fatigue zone with a smooth surface and progression lines over almost the whole surface of the fracture on the right side.On the left side is a fatigue zone with a smooth surface and progression lines on about half of the surface, the rest of the surface is the instantaneous zone, where the nail finally broke apart.At the entry point of the hole are stress marks from reaming and a deformation visible (red arrow).Afterwards it cannot be defined if this deformation was caused during reaming or because the fragments did rub against each other in this area after the breakage.At the other side of the hole are very strong impression marks from the u-blade visible, these marks indicate that the nail was exposed to high loads over a longer 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.The broken nail was returned for evaluation and no product related issue could be detected.There was no additional information about the event provided, the implant date is unknown and neither x-rays, nor operation report, nor information about patient activity was available.Therefore the root cause of the breakage cannot be defined.The evaluation of the nail has shown that fatigue did lead to the breakage of the device.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.".
Event or Problem Description
As reported:" postoperatively gamma3 long nail was broken and a revision surgery was performed.The broken part is the lag screw hole.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X360MM 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: 15963396
• Report Number: 0009610622-2022-00577
• Device Sequence Number: 20227268
• Product Code: HSB
• UDI-Device Identifier: 04546540375742
• UDI-Public: 04546540375742
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Expiration Date: 11/30/2025
• Device Model Number: 3525-0360S
• Device Catalogue Number: 35250360S
• Device Lot Number: K08703B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2020
• 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 Sex: Unknown