MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3125-1200S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	12/13/2022
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.
Event or Problem Description
As reported: "pain in the operated area without trauma with significant increase in the course.X-ray diagnosis revealed sintering of the gamma nail with fracture of the distal locking screw.Patient was operated again.".
Additional Manufacturer Narrative
Please note correction to h6 (device code).The reported event could be confirmed since the device was returned and matches the alleged failure.Device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Heavy explantation marks were observed on the inner surface of the hole and the fracture surface as well, mostly in the distal segment.We can see the load-bearing points on the proximal part of the broken nail which indicates overloading.We can also see the presence of breakage in an oblique manner which indicates towards application of high torsional load.Bearing points of the lag screw at the medial edge of the proximal hole showed significant deformation, indicating the high compressive load.Signs of overloading were also evident at the distal oblong hole.The breakage pattern resembles a fatigue breakage, having equal portions of fatigue zone and instantaneous zone indicating that the breakage was initiated in a fatigued manner but quickly broke instantaneously under high compressive loading.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 the investigation, the root cause was attributed to patient related factors as breakage was due to high compressive load and with available overloading signs on nail.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "pain in the operated area without trauma with significant increase in the course.X-ray diagnosis revealed sintering of the gamma nail with fracture of the distal locking screw.Patient was operated again.".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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: 16491699
• Report Number: 0009610622-2023-00075
• Device Sequence Number: 5660030
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: 04546540375087
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 09/30/2024
• Device Model Number: 3125-1200S
• Device Catalogue Number: 31251200S
• Device Lot Number: K038623
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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: 88 YR
• Patient Sex: Female