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

Model Number	3005-1105S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "on (b)(6) 2023, according to the letter received from the ministry, the moh received the adverse event report prepared by ankara atatürk sanatorium research hospital.In the letter; it is stated that the product was broken after implantation.The incident was reported to us by the ministry of health in a letter dated (b)(6) 2023.The case was dated (b)(6) 2022, but we have no information about when the implant broke." new information received (b)(6) 2023.The patient named was operated by us in march 2022 for intertrochanteric femur fracture and the nail named ¿gamma3® nail¿.In august 2022, the patient applied to us with pain in the hip without describing any trauma, and the x-rays showed that the nail itself (not the ¿end cap¿) was broken.The patient was re-operated for a revision surgery using a different brand of cephalomedullary nail.The patient was in his 80s and his body mass index was within normal limits.The patient¿s first operation was successful without any problem and fully in accordance with the instructions for use of the related nail.As seen in the x-rays, both the fracture reduction and the nail placement were performed in accordance with the medical rules.The patient has undergone a postoperative mobilisation protocol in accordance with the medical literature.The patient was observed to fully comply with the recommended protocol during follow-up.The patient applied to us with hip pain 5 months after the operation without any history of fall.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note correction to d9/h3.The reported event could be confirmed, since nail breakage was evident on the received x-rays.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 or design related problems were found during the investigation.In the case presented a male patient (no patient data given) had been treated with above nail on (b)(6) 2022.On (b)(6) 2022, the patient appeared with pain in the hospital and the patient was revised for a broken nail.The broken product was not returned for investigation.A brief summary of the patient¿s history and 6 x-ray copies were provided.The medical records were forwarded to a medical expert for review.His comment: ¿the patient is presenting a reversed oblique pertrochanteric femoral fracture with a long lateral spike and a dislocation and proximalisation of the lesser trochanter and loss of the medial bone support.This is known to cause healing problems and might be associated with a prolongation of union or a non-union.The x-ray shows a very good surgical reduction and an almost perfect positioning of the nail.The lesser trochanter has not been restored though.Conclusion: the non-union is patient related due to the unfavorable fracture pattern.A reposition of the lesser trochanter could have been considered from the surgeon¿s perspective.In the end non-union occurred and a pretty early fatigue breakage of the nail occurred.Usually, we expect the nail to provide stability for at least 6 months¿however, the load in this specific clinical situation is pretty high on the nail and therefore the breakage as a consequence of the prolonged healing period is not completely surprising.¿ if the device is returned or if any additional information is provided, the investigation will be reassessed.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by patient factors.H3 other text: device disposition unknown.
Event or Problem Description
As reported: "on (b)(6) 2023, according to the letter received from the ministry, the moh received the adverse event report prepared by (b)(6) hospital.In the letter; it is stated that the product was broken after implantation.The incident was reported to us by the ministry of health in a letter dated on (b)(6) 2023.The case was dated on (b)(6) 2022, but we have no information about when the implant broke." new information received 02 mar 2023.The patient named was operated by us on (b)(6) 2022 for intertrochanteric femur fracture and the nail named ¿gamma3® nail¿.On (b)(6) 2022, the patient applied to us with pain in the hip without describing any trauma, and the x-rays showed that the nail itself (not the ¿end cap¿) was broken.The patient was re-operated for a revision surgery using a different brand of cephalomedullary nail.The patient was in his 80s and his body mass index was within normal limits.The patient¿s first operation was successful without any problem and fully in accordance with the instructions for use of the related nail.As seen in the x-rays, both the fracture reduction and the nail placement were performed in accordance with the medical rules.The patient has undergone a postoperative mobilisation protocol in accordance with the medical literature.The patient was observed to fully comply with the recommended protocol during follow-up.The patient applied to us with hip pain 5 months after the operation without any history of fall.

• 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: 16522456
• Report Number: 0009610622-2023-00080
• Device Sequence Number: 11366497
• Product Code: HSB
• UDI-Device Identifier: 04546540374868
• UDI-Public: 04546540374868
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2023

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: 12/31/2025
• Device Model Number: 3005-1105S
• Device Catalogue Number: 31251200S
• Device Lot Number: K0DA517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2021
• 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 Sex: Male