MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-EX; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.008.007
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that the hindfoot arthrodesis nail set - underwent tray audit and preventative maintenance.The instruments require replacement as the entire aiming arm seems to be missing the nail during drilling/screw insertion.No patient consequences reported.No further information provided.This report is for one (1) insertion handle f/hindfoot arthrodesis nail-ex.This is report 2 of 5 for (b)(4).

• Brand Name: INSERTION HANDLE F/HINDFOOT ARTHRODESIS NAIL-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: 11101747
• Report Number: 2939274-2020-05803
• Device Sequence Number: 4140201
• Product Code: FZX
• UDI-Device Identifier: 10886982066855
• UDI-Public: 10886982066855
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: 03.008.007
• Device Catalogue Number: 03.008.007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/31/2020
• 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: AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL; HANDLE WITH MINI QUICK COUPLING; HOLDING DEVICE FOR GUIDE WIRES AND REAMING RODS; THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL; THREADED ALIGNMENT PIN F/HINDFOOT ARTHRODESIS NAIL