MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3130-1180S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device disposition unknown.
Event or Problem Description
As reported: "gamma3 nail broke two months after implantation and had to be removed again.The patient had to undergo a second surgery, during which the broken gamma nail had to be removed and a new nail inserted".
Event or Problem Description
As reported: "gamma3 nail broke two months after implantation and had to be removed again.The patient had to undergo a second surgery, during which the broken gamma nail had to be removed and a new nail inserted".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More information as well as the affected device must be available in order to determine the exact root cause of the failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Additional Manufacturer Narrative
Please note correction to h6 (method, results, and conclusion codes) the reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.It was not communicated in which leg the nail was placed.Severe drill marks were found at the lateral entrance of the hole along one of the sides of the proximal segment; they progress slightly inwards through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture notching effect somewhere at the lateral edge.The misdrilling is majorly evident only on the proximal aspect of the through hole.Another thing to note apart from the drill marks was the sign of excessive loading.Bearing points of lag screw at the lateral edge of the proximal part showed slight deformation.The medial edge of the distal part also showed signs of deformation, heavier than the proximal one.This indicates towards application of high compressive load.The fracture pattern resembles a fatigue fracture, evident by appearance of very slight lines of rest and shiny fracture surface.The breakage initiated in a fatigue manner from the side where drill marks could be seen and broke in a much quicker manner from the other side due to high tension and loading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and available information, the cause of the breakage can be attributed to both patient and user related factors but predominantly patient related.The deformation of the lateral and medial edges of the nail indicates towards excessive loading on the nail.Weakening of the whole construct due to intra-op misdrilling could have also initiated the breakage.The operative technique clearly provides a warning to the user that: "warning: in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture." the instruction for use clearly instructs the user that: ¿these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason post-operative instructions and warnings to patients are extremely important.External immobilization e.G.Bracing or casting may be employed until x-rays or other procedures confirm adequate bone consolidation.[¿]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 any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "gamma3 nail broke two months after implantation and had to be removed again.The patient had to undergo a second surgery, during which the broken gamma nail had to be removed and a new nail inserted".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X180MM X 130°
• 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: 16060774
• Report Number: 0009610622-2022-00604
• Device Sequence Number: 13958272
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: 04546540375124
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K200869
• 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,Followup
• Report Date (Section B): 05/23/2023

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: 3130-1180S
• Device Catalogue Number: 31301180S
• Device Lot Number: K06A155
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 01/31/2023; 04/25/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 02/17/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2021
• 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: 44 YR
• Patient Sex: Male