MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 110MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.310S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 172.72 cm.Complainant part is not expected to be returned for manufacturer review/investigation.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided is not valid.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 that a patient who underwent a trochanteric fixation nail advanced (tfna) implant on (b)(6) 2018, was revised to a total hip arthroplasty on (b)(6) 2018, due to what looked like an impending cut out of the helical blade.Reportedly the patient was healing but post-operative x-rays showed that the device appeared to be on its way to cut out due to his very osteoporotic bone.The helical blade, the trochanteric fixation nail, and one 5.0 titanium locking screw were removed intact without any additional medical intervention or intraoperative events.The patient was successfully revised with no surgical delays and was reported to be stable at the end of the procedure.Concomitant devices reported: 11mm 130 degree titanium cannulated trochanteric fixation nail- advanced (part 04.037.144s, lot number h488085, quantity 1), 5.0mm titanium locking screw with t/25 stardrive 48mm for intramedullary nails (part 04.005.538, lot number unknown, quantity 1).This report is for one (1) tfna helical blade this is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 110MM 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7401258
• MDR Text Key: 104530234
• Report Number: 2939274-2018-51486
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099075
• UDI-Public: (01)10886982099075(17)EXPIRATIONUNKNOWN(10)H33847
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/13/2018

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
• Device Operator: Health Professional
• Device Model Number: 04.038.310S
• Device Catalogue Number: 04.038.310S
• Device Lot Number: H33847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 89