MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10 TI CANN RETRO/ANTEGRADE FEM NL/340-S; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.448S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: hwc.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) 2021, during an unknown procedure, the retrograde femoral nail was broken.The nail broke at the junction of the second locking hole after the spiral blade, because of a three-year-old non-union.The original surgery was on (b)(6) 2018 with periprosthetic distal femoral fracture with long retrograde nail/spiral blade.Surgical procedure was successfully completed without surgical delay.Concomitant devices reported: titanium spiral blade (part# unknown, lot# unknown, quantity 1), titanium end cap (part# unknown, lot# unknown, quantity 1), and titanium locking screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) 10 ti cann retro/antegrade fem nl/340-s.This is report 1 of 1 for (b)(4).

• Brand Name: 10 TI CANN RETRO/ANTEGRADE FEM NL/340-S
• 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: 11651549
• Report Number: 2939274-2021-01810
• Device Sequence Number: 11683166
• Product Code: HSB
• UDI-Device Identifier: 10886982087867
• UDI-Public: 10886982087867
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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: 04.013.448S
• Device Catalogue Number: 04.013.448S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 94