MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	456.315S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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
It was reported that during a revision procedure on (b)(6) 2021, a short titanium trochanteric fixation nail (tfn) was removed due to a fracture distal to end of the nail.The tfn nail broke at the distal screw holes when it was being extracted.The broken fragment was then pushed out of the fracture site.The short tfn nail was then replaced with a long tfn nail.There was a surgical delay of 30 minutes.The procedure was successfully completed.This report captures the intra-op event of tfn nail breakage while related complaint (b)(4) captures the post-op of event of short tfn removal due to a fracture distal to the end of the nail.This report is for 1 10mm/130 deg ti cann troch fixation nail 170mm.This is report 1 of 1 for (b)(4).

• Brand Name: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM
• 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: 11531977
• Report Number: 2939274-2021-01463
• Device Sequence Number: 14744986
• Product Code: HSB
• UDI-Device Identifier: 10886982226907
• UDI-Public: (01)10886982226907
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 02/22/2021

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: 456.315S
• Device Catalogue Number: 456.315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/19/2021
• Patient Sequence Number: 1
• Patient Age: 76 YR