MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.052
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.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, during an intramedullary nailing system of the proximal tibia fracture, when the surgeon attempted to place an anterior to posterior unknown screw in an unknown tibial nail, the aiming arm for titanium cannulated tibial nail would not accept cannulas.Different unknown proximal screws were selected to complete the surgery successfully.There was no surgical delay reported.There was no patient consequence reported.Concomitant medical products: unknown screw (part# unknown, lot# unknown, quantity unknown).Unknown nail (part# unknown, lot# unknown, quantity 1).Unknown insertion handle (part# unknown, lot# unknown, quantity 1).This report is for one (1) aiming arm for ti cannulated tibial nails-ex.This is report 1 of 2 for (b)(4).

• Brand Name: AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX
• 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: 10448326
• Report Number: 2939274-2020-03769
• Device Sequence Number: 3903441
• Product Code: FZX
• UDI-Device Identifier: 10886982067241
• UDI-Public: 10886982067241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/30/2020

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: 03.010.052
• Device Catalogue Number: 03.010.052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/25/2020
• 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: UNK - NAIL INSERTION HANDLES: RADIOLUCENT.; UNK - NAILS: TIBIAL.; UNK - SCREWS: TRAUMA.