MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.195S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hsb.Device has not been reported as explanted.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.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 on (b)(6) 2018, during a trochanteric fixation nail advance (tfna) procedure, the surgeon had difficulty inserting the lag screw due to the helical blade/screw coupling screw and insertion handle became cross threaded during insertion.It was unknown if other devices were used, but the lag screw was successfully inserted.The procedure was successfully completed and there was no surgical delay.There was no surgical delay.Patient outcome is unknown.Concomitant devices reported: tfna nail (part/lot unknown, quantity 1).This report is for a tfna fenestrated screw.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 95MM - 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: 8223630
• Report Number: 2939274-2019-55727
• Device Sequence Number: 1670307
• Product Code: HSB
• UDI-Device Identifier: 10886982098757
• UDI-Public: (01)10886982098757
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.195S
• Device Catalogue Number: 04.038.195S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1