MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.037.128S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as 5¿0.Date of implant/explant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported patient was implanted with the trochanteric fixation nail advanced (tfna) nail, helical blade, and two (2) locking screws on unknown date.On another unknown date, it was revealed the tfna nail broke where it interfaces with the helical blade.Patient was returned to surgery on unknown date and revised to a total hip construct.Concomitant devices reported: tfna helical blade 85mm (04.038.285s, lot number unknown, quantity 1), 5.0mm locking screw with t25 stardrive 40mm (04.005.530s, lot number unknown, quantity 1), 5.0mm locking screw with t25 stardrive 64mm (04.005.554, lot number unknown, quantity 1).This report is for one (1) 11mm 125 degree tfna nail 380mm.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7781255
• Report Number: 2939274-2018-53317
• Device Sequence Number: 2336665
• Product Code: HSB
• UDI-Device Identifier: 10886982096425
• UDI-Public: (01)10886982096425
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.037.128S
• Device Catalogue Number: 04.037.128S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/14/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 79