MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 95MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.295
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id and weight were not provided for reporting.Date of event is unknown.Exact date of implant is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 report that the patient had original surgery sometime in (b)(6) 2017 for treatment of a left femur fracture.Patient was implanted with one (1) cannulated trochanteric fixation nail advanced (tfna), one (1) helical blade and one (1) distal locking screw.On an unknown date post-operative, patient presented with the helical blade implant cutting out of the femur neck bone.On (b)(6) 2017, surgeon removed all implants and revised the patient to a femur plate and screws.It was reported that no fragments were generated during implant removal.Revision surgery was completed successfully with no time delay.Patient was reported in stable condition.Concomitant devices reported: 11 mm/130 mm cannulated trochanteric fixation nail advanced (part# 04.037.142s, lot# unknown, quantity 1).Tfn-advanced screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) tfna helical blade 95 mm.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA HELICAL BLADE 95MM
• 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: 7147807
• Report Number: 2939274-2017-50441
• Device Sequence Number: 19118763
• Product Code: HSB
• UDI-Device Identifier: 10886982099006
• UDI-Public: (01)10886982099006(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2017

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: 04.038.295
• Device Catalogue Number: 04.038.295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/27/2017
• 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: 76 YR