MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.263S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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) 2019, the patient underwent revision surgery due to broken proximal femoral nailing system (tfna) nail with non-union of subtrochanteric fracture intramedullary nail left femur.Patient previously treated for fracture due to cancer.Patient experience a post-op device malfunction.Nail broke at proximal junction of lag screw.The tfna screw was intact and successfully removed.Pain was experienced before revision surgery not after.The original date of implant was on (b)(6) 2018.Removal of nail and lag screw was successful and patient was implanted with tfn nail and tfn lag screw.There was no surgical delay reported.Procedure outcome was successful.Patient consequences experienced pain due to broken nail/non-union of the fracture site.Concomitant devices reported: tfna screw 115mm (part# 04.038.115, lot# unknown, quantity# 1) unknown screws: locking (part# unknown, lot# unknown, quantity# 1).This report is for one (1) tfna nail.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILE
• 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: 8809126
• Report Number: 2939274-2019-59295
• Device Sequence Number: 321047
• Product Code: HSB
• UDI-Device Identifier: 10886982097439
• UDI-Public: (01)10886982097439
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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: 04.037.263S
• Device Catalogue Number: 04.037.263S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TFNA SCREW 115MM; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91