MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0300S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.The device remains implanted in the patient.
Event or Problem Description
As reported; "the gamma3 nail was implanted into the left thigh on (b)(6) 2022.On (b)(6) 2023, fracture of the nail was found.The revision surgery for replacing the fractured nail is scheduled on (b)(6) 2023.".
Event or Problem Description
As reported; "the gamma3 nail was implanted into the left thigh on (b)(6) 2022.On (b)(6) 2023, fracture of the nail was found.The revision surgery for replacing the fractured nail is scheduled on (b)(6) 2023." additionally, the doctor reported that the patient fell down often.
Additional Manufacturer Narrative
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.Severe drill marks were found at the lateral entrance of the hole along the anterior web; they progress 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 missdrilling is majorly evident only on the distal 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 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 nature of breakage was determined to be fatigue fracture.Evidence of intra-op missdrilling in the nail indicates towards a user related error.Also, deformation on the medial edge is indicative of application of high loading.It is not possible to ascertain any patient related factors without more patient details and radiographs, though it was communicated that the patient fell a few times post-op.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."[original statements] if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X300MM 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: 16678164
• Report Number: 0009610622-2023-00098
• Device Sequence Number: 14811273
• Product Code: HSB
• UDI-Device Identifier: 04546540375711
• UDI-Public: 04546540375711
• 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 Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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: 05/31/2026
• Device Model Number: 3525-0300S
• Device Catalogue Number: 35250300S
• Device Lot Number: K0E6E74
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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: 85 YR
• Patient Sex: Female