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

Model Number	04.038.310S
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 7401258
• Report Number: 2939274-2018-51486
• Device Sequence Number: 16511494
• Product Code: HSB
• UDI-Device Identifier: 10886982099075
• UDI-Public: (01)10886982099075(17)EXPIRATIONUNKNOWN(10)H33847
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 04.038.310S
• Device Catalogue Number: 04.038.310S
• Device Lot Number: H33847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• 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: 84 YR
• Patient Weight: 89