MAUDE Adverse Event Report: U&I CORPORATION DYNA LOCKING TROCHANTERIC NAIL; INTRAMEDULLARY FIXATION ROD

Model Number	NGA2100
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Phenomenon analysis: cut-out is generally well-known as the problem which could be possibly happened after operating the surgery using femoral nail to patients roughly aged over 70 considering the bone density is getting lower as per aging.According to the literature review, the incident rate of cut-out is average on 3.0%(0%~14.9%).(reviewed literatures are attached in this report.) wedge wing, the component which would help the neck screw not to be migrated was not used in the surgery.And by observing some scratches on returned product as well as the x-ray picture showing neck screw is considerably migrated, it is assumed that the fixed nail cap was not optimally placed to the neck screw, followed by the migration as micro-motion was generated by the patient in his daily life.Records review: patient is a korean and this incident happened in korea.We have reviewed the device history record (manufacturing & inspection ) of the relevant products, however, we cannot find any quality problem in those records.Progress on the patient: on (b)(6) 2020, the patient got total hip replacement surgery on the same area as additional surgery after explanting the implants.The patient's condition is going to be consistently monitored.
Event or Problem Description
After undergoing trochanteric nail insertion surgery on (b)(6) 2020, the patient started to feel pain in the surgery area.Subsequently the patient visited the hospital on (b)(6) 2020 and it was confirmed that cut-out was observed as the neck screw entered acetabulum.The relevant implants were removed on (b)(6) 2020 then total hip replacement was performed on the patient in the other hospital.

• Brand Name: DYNA LOCKING TROCHANTERIC NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): U&I CORPORATION; 20, sandan-ro 76 beon-gil; uijeongbu-si, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 10639771
• Report Number: 9617297-2020-00006
• Device Sequence Number: 19745180
• Product Code: HSB
• UDI-Device Identifier: 08800015918060
• UDI-Public: (01)08800015918060(11)190926(10)19I23007
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

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: NGA2100
• Device Catalogue Number: NGA2100
• Device Lot Number: 19I23007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR