MAUDE Adverse Event Report: INNOSYS CO., LTD. DYNA LOCKING TROCHANTERIC NAIL; INTRAMEDULLARY FIXATION ROD

Model Number	NG1220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This issue occurred in korea.On (b)(6) 2023 the patient had a surgery to implant the dyna locking trochanteric nail system.The fracture of the trochanteric nail 130-12x200mm was confirmed through an x-ray review conducted 7 days after the surgery.
Additional Manufacturer Narrative
Results of investigation: upon reviewing the production and inspection records of the fractured trochanteric nail, it was confirmed that it was manufactured properly.Upon examination of the retrieved nail, it was observed that the inside of the nail hole was deeply indented, likely due to the neck screw.This suggests that the fracture occurred due to patient-related factors.The probable cause of this problem (early fracture of implant) is attributed to the weight-bearing (e.G., walking practice shortly after surgery) or external impact (e.G., a fall) on the implant by the elderly patient before complete bone union.Based on the literature review, after femoral bone fracture treatment, it is recommended to allow joint movement without weight-bearing for up to 7 days, and partial weight-bearing walking exerciess with crutches or a walking aid can start from 10 days (stable fractures) to 3 weeks (unstable fractures) after the surgery.(s.S kim, hip pelvis 25(3)2013) furthermore, restricting weight-bearing after surgery has been found to reduce potential complications in elderly patients.(c gunay, acta orthop.Belg., 80, 2014).Additionally, physical damage (scratches) from the surgical procedure (reaming) was observed on the exterior of the nail.Such damage can act as a stress-rising factor.Current status: we have provided feedback to the user based on the investigation july 12, 2023.And after confirming the fracture of the nail, the fractured implant was removed and a reoperation was successfully completed on (b)(6) 2023.As of now, there are no specific health issues identified and we will continue to monitor the patient's health condition.

• Brand Name: DYNA LOCKING TROCHANTERIC NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): INNOSYS CO., LTD.; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• Manufacturer Contact: ye-seul choi ; 20 sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 17339949
• Report Number: 9617297-2023-00001
• Device Sequence Number: 17870770
• Product Code: HSB
• UDI-Device Identifier: 08800015916974
• UDI-Public: (01)08800015916974(11)180917(10)18H217
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093707
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Replace,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 07/17/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: NG1220
• Device Catalogue Number: NG1220
• Device Lot Number: 18H217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2018
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian