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

Catalog Number	31251200S
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
A nail breakage was reported.A revision surgery is required.The date of revision is not reported.
Additional Manufacturer Narrative
Correction please refer to d4 lot#.The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: during visual inspection.The nail found completely broken from the webs of the lag screw hole.Drilling marks are visible in the anterior web of lag screw hole starting from lateral side most probably due to contact of drill with the nail prior to lag screw insertion.Drilling marks are also visible in both the distal holes.Excess contact of the drill with the nail affects the loading bearing capacity of the nail and could create a starting point of the fracture (notching effect).Heavy deformation is observed in the distal fragment of the broken nail in the medial position of the nail along with two load bearing points.Lateral side is also rubbed shiny and deformed.This indicates that the distal fragment of the nail has been subjected heavy compressive load.The microscopic view of the broken fragment¿s surface indicates towards a fatigue failure as indicated by the lines of rest on the surface.A formal medical opinion was sought regarding the received x-rays and medical documents which states that "unfortunately the quality of the shared x-rays is very bad which makes a determination of the root cause impossible".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, we can say that the nail breakage occurred in a fatigue manner.Miss-drilling could be a potential factor towards nail breakage as it affects the load bearing capacity of nail and makes it prone to breakage but as the evaluation of the x-rays was not possible due to bad quality, an exact root cause cannot be established.If more information is provided, the case will be reassessed.
Event or Problem Description
A nail breakage was reported.A revision surgery is required.The date of revision is not reported.Additionally reported: material failure with fracture of the gamma nail in the presence of pseudarthrosis of the proximal femur with status post gamma nail osteosynthesis for multifragmentary pertrochanteric femoral fracture on the left side.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 Ø11X200MM X 125°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19735685
• Report Number: 0009610622-2024-00706
• Device Sequence Number: 7006238
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: (01)04546540375087(11)230825(17)280731(10)K16BD0C
• 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: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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 Catalogue Number: 31251200S
• Device Lot Number: K16BD0C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2023
• 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: 81 YR
• Patient Sex: Female