MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.955S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2020, the surgeon`s patient presented with a broken tfn-advanced system, long nails, 9mm distal diameter at the lag screw/helical blade insertion junction.The original surgery was done in 2017 to treat a cancerous lesion.The 85mm lag screw was still in tact as well the 40mm distal locking screw.The surgeon successfully removed all implants, including the broken tfna nail.No hardware remained implanted.A 10x340, 130 degree tfna nail, 85mm lag screw, and a 40mm and 48mm locking screws were implanted successfully to address the patients delayed non-union.Procedure outcome is unknown.There was a patient consequence.Concomitant device reported: unk - nail head elem: tfna lag screw (part# unknown; lot# unknown; quantity: unknown), unk - screw:locking (part# unknown; lot# unknown; quantity: unknown).This report is for 1 9mm/130 deg ti cann tfna 340mm/left - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 9MM/130 DEG TI CANN TFNA 340MM/LEFT - STERILE
• 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: 10684666
• Report Number: 2939274-2020-04683
• Device Sequence Number: 19695368
• Product Code: HSB
• UDI-Device Identifier: 10886982098153
• UDI-Public: (01)10886982098153
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

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: 04.037.955S
• Device Catalogue Number: 04.037.955S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention