MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ROD, FIXATION, INTRAMEDULLARY

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown this report is for an unknown tfna nail/unknown lot.Part and lot number are unknown; udi number is unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 there was difficulty removing the insertion handle from the trochanteric fixation nail advanced (tfna) nail during a trochanteric fixation nail advanced (tfna) procedure on (b)(6) 2018.The surgeon had to chisel away the top of the connecting screw to get the screw out, which extended the surgery by ten (10) minutes.The patient was reported to be doing fine at the end of the surgery.This report is for an unknown tfna nail.This is report 2 of 3 for (b)(4).

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7659108
• MDR Text Key: 113042727
• Report Number: 2939274-2018-52703
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• 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