MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA SCREW 80MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.080S
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Device malfunctioned intra-operatively and was not explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 lag screw was misaligned and two drill bits broke during a femoral nailing procedure on (b)(6) 2018.The tip of a 10mm cannulated tapered drill bit broke off while the surgeon was opening the lateral cortex.Then, a 6mm/9mm cannulated stepped drill bit broke while the surgeon was reaming the femoral head.Fragments were left in the bone from both broken bits.The lag screw for trochanteric fixation nail advanced (tfna) went anterior to the nail; this was caught in final fluoroscopy toward the end of the procedure and had to replaced the device.It backed out, the handle placed back on the nail and the same lag screw was shot (implanted) in the right trajectory.There was a surgical delay of about two hours due to these malfunctions, therefore and extra fluoroscopy was required.The procedure was completed successfully with the patient in stable condition.Concomitant device report: [unknown aiming arm] (part #: unknown, lot #: unknown, quantity: 1), [unknown trocars] {part #: unknown, lot #: unknown, quantity: 3), [unknown stryker power drill] (part #: unknown, lot #: unknown, quantity: 1).This complaint is for three (3) devices.This report is 3 of 3 for (b)(4).
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Patient date of birth and weight not available for reporting.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.

• Brand Name: TFNA SCREW 80MM - 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: 7290553
• Report Number: 2939274-2018-50740
• Device Sequence Number: 16738961
• Product Code: HSB
• UDI-Device Identifier: 10886982098436
• UDI-Public: (01)10886982098436(10)LOTUNK
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2018

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: 04.038.080S
• Device Catalogue Number: 04.038.080S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR