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

Model Number	NG1120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We asked the hospital and the distributor for more information about the patient regarding the customer complaint, but were unable to obtain any information other than age and gender.Reanalysis of the chemicals and mechanical properties, dimensions and appearance of the damaged product found them to be within acceptable criteria, and the entire production and inspection records showed no abnormalities.It seems that the reason why implant was damaged in 10 months after surgery on december 20, 2018 is because of various factors such as patient age, history (e.G.Osteoporosis), and activity.In a related paper*, we found that the rate of breakage of other companies' products was between 0.2% and 5.7%, higher than the rate of breakage of our products, 0.04%.Breakage of a third generation gamma nail: a case report and review of the literature.
Event or Problem Description
This event occured in south korea.The female patient underwent surgery for implanting dyna locking trochanteric nail system on (b)(6) 2018.It is confirmed that the trochanteric nail 130-11x200mm(ng1120) has been broken in the patient body postoperatively after around 10 months ((b)(6) 2019) and the revision surgery was conducted for removing the nail ((b)(6) 2019).

• Brand Name: DYNA LOCKING TROCHANTERIC NAIL
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): U&I CORPORATION; 20, sandan-ro, 76beon-gil; uijeongbu, 11781 ; KS 11781
• MDR Report Key: 9400194
• Report Number: 9617297-2019-00005
• Device Sequence Number: 2167606
• Product Code: HSB
• UDI-Device Identifier: 08800015916509
• UDI-Public: (01)08800015916509(11)181102(10)181282-1
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: NG1120
• Device Catalogue Number: NG1120
• Device Lot Number: 18I282-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/03/2019
• 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: Required Intervention
• Patient Age: 70 YR