MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 85MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.385S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an unknown date in 2019.Additional procode: ktt.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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 patient underwent hip surgery revision on (b)(6) 2019, due to trochanteric fixation nail advance (tfna) augmentation cutout.The whole construct cut out of the bone.The initial implant was on (b)(6) 2019.Procedure outcome is unknown.There was no patient consequence.Concomitant devices: distal locking screw (part: unknown, lot: unknown, quantity: unknown).This report is for a tfna fenestrated helical blade.This is report 1 of 3 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 85MM - 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: 8469078
• Report Number: 2939274-2019-57197
• Device Sequence Number: 16589637
• Product Code: HSB
• UDI-Device Identifier: 10886982099235
• UDI-Public: (01)10886982099235
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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: 04.038.385S
• Device Catalogue Number: 04.038.385S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention