MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.013.000
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
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 an unknown date, the patient underwent a procedure to treat a distal femur fracture with synthes retrograde nail as fixation.During surgery the end cap for a retrograde nail fell off the insertion t40 star drive screwdriver handle.The surgeon failed to get the item out of the patients canal and therefore left the item in the patient.The procedure was completed successfully with a ten (10) minute surgical delay.Concomitant device reported: unk - nails: rafn (part# unknown; lot# unknown; quantity: 1).Unk - screwdriver: handle (part# unknown; lot# unknown; quantity: 1).This report is for one (1) ti end cap t40 strdrv 0mm ext retro femoral nail-ex sprl bld.This is report 1 of 1 for (b)(4).

• Brand Name: TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12640144
• Report Number: 2939274-2021-06127
• Device Sequence Number: 19686453
• Product Code: HSB
• UDI-Device Identifier: 10886982087348
• UDI-Public: 10886982087348
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.013.000
• Device Catalogue Number: 04.013.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - NAILS: RAFN; UNK - SCREWDRIVERS
• Outcome Attributed to Adverse Event: Required Intervention