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

Catalog Number	NG1120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the broken trochanteric nail is unknown.The trochanteric nail broke into two pieces.One was discarded by nurse.Therefore, we are unable to review device history records and check function or dimensions.When we survey the incidence of breakage of another company products through the associated paper, the incidence of breakage ranges between 0.2% and 5.7%.The incidence of breakage of our product is (b)(4) and lower than them.
Event or Problem Description
This event occurred in (b)(6).A patient underwent surgery on (b)(6) 2018.A 130-11x200mm trochanteric nail was broken in patient postoperatively.The broken trochanteric nail was removed and replaced with another products on (b)(6) 2018.It was reported that after revision surgery, the patient left the hospital as good.

• Brand Name: DYNA LOCKING TROCHANTERIC NAIL SYSTEM
• Common Device Name: INTRAMEDULLARY FIXATION ROD
• Manufacturer (Section D): U&I CORPORATION; 20,sandan-ro,76beon-gil; uijeongbu, gyeonggi-do 11781 ; KS 11781
• MDR Report Key: 7800186
• Report Number: 9617297-2018-00008
• Device Sequence Number: 1142944
• Product Code: HSB
• UDI-Device Identifier: 08800015916509
• UDI-Public: 08800015916509
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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 Catalogue Number: NG1120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/21/2018
• 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: 64 YR