MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10 TI LFN RECON NAIL-EX/380/LT-SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.003.357S
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
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 history lot - no ncr's were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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, during a procedure the tooth on the insertion handle broke off, not allowing the nail to engage.The surgeon had to switch systems and use another nail instead.Procedure was completed successfully with five(5) minutes surgical delay.This report is for one (1) 10mm ti lateral entry femoral recon nail-ex/380mm/lt-sterile.This is report 3 of 3 for complaint (b)(4).

• Brand Name: 10 TI LFN RECON NAIL-EX/380/LT-SILE
• 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: 12594457
• Report Number: 2939274-2021-05964
• Device Sequence Number: 4459925
• Product Code: HSB
• UDI-Device Identifier: 10886982082060
• UDI-Public: (01)10886982082060
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2021

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: 04.003.357S
• Device Catalogue Number: 04.003.357S
• Device Lot Number: H590559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2021
• Initial Report FDA Received Date: 10/07/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANN CNCT SCR INTNL THRD PERC INSRN HNDL; RADIOLUCENT INSRT H&LE FOR EXPERT NL/100