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

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Type  Injury  

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 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
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7781255
• MDR Text Key: 117130713
• Report Number: 2939274-2018-53317
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096425
• UDI-Public: (01)10886982096425
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.128S
• Device Catalogue Number: 04.037.128S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 79