MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.130S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) 2020, during an open reduction internal fixation (orif) of the right femur while inserting the unknown helical blade for the trochanteric femoatal nail advanced (tfna) system, the unknown blade missed the tfna nail.The surgeon took the nail out and started over with a new unknown nail.The surgeon used the same unknown helical blade and this time it went fine.The procedure was completed successfully with a surgical delay of twenty-five (25) minutes.The patient outcome was unknown.Concomitant devices reported: unknown helical blade (part# unknown, lot# unknown, quantity).Unknown helical blade inserter (part# unknown, lot# unknown, quantity).Unknown spiral combination hammer (part# unknown, lot# unknown, quantity).This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/125 DEG TI CANN TFNA 400MM/RIGHT - 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: 10426792
• Report Number: 2939274-2020-03655
• Device Sequence Number: 2854229
• Product Code: HSB
• UDI-Device Identifier: 10886982096449
• UDI-Public: (01)10886982096449
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2020

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: 04.037.130S
• Device Catalogue Number: 04.037.130S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1