MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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) 2020, patient underwent hip intramedullary nailing, during the procedure the connecting nut of 130 degree tuna trochanteric fixation nail advanced (tfna) aiming arm broke during assembly.The connecting nut was referring to the connecting screw for 130 aiming guide.The aiming arm was not properly secured to trochanteric fixation nail advanced (tfna) insertion handle.This made it difficult to insert guide wire properly.Pliers were used to secure the aiming arm.The guidewire was eventually inserted where it was needed.There was a surgical delay of five (5) minutes.There were fragments generated from broken device, the screw broke perfectly in half.The two fragments were easily removed from the field with no additional intervention.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: nails: tfna (part number unknown, lot unknown, quantity 1), 130 deg aiming arm (part number 03.037.013, lot 9282818, quantity 1), nail insertion handles (part number unknown, lot unknown, quantity 1), guide/compression/k-wires (part number unknown, lot unknown, quantity 1).This report involves one (1) connecting screw f/guide wire aiming device f/tfn.This is report 2 of 3 for (b)(4).

• Brand Name: CONNECTING SCREW F/GUIDE WIRE AIMING DEVICE F/TFN
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10476275
• Report Number: 2939274-2020-03885
• Device Sequence Number: 2628342
• Product Code: FZX
• UDI-Device Identifier: 10886982068590
• UDI-Public: (01)10886982068590
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 03.010.415
• Device Catalogue Number: 03.010.415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130 DEG AIMING ARM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - NAIL INSERTION HANDLES; UNK - NAILS: TFNA