MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI SPIRAL BLADE 85MM FOR TI RETROGRADE FEMORAL NAILS-EX; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.013.049

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that on (b)(6) 2021 a retrograde nail exchange was done because of a possible infection and nonunion.The original injury was done due to a gunshot to the distal femur.The nail and hardware were successfully exchanged.There was one (1) 5.0mm broken screw proximally that was successfully removed.While inserting the new nail, the surgeon hit the nail with the second most distal screw drill bit.However, adjustments were made and the surgeon was able to place the screw successfully.The surgeon was leaning on the aiming arm causing it to bend and miss the nail.There was a twenty (20) minutes surgical delay.Patient outcome is reported as good.This report captures the post-op event of possible infection and nonunion while related complaint (b)(4) captures the intra-op event during insertion of the new nail the surgeon hit the nail with the second most distal screw drill bit.This report is for one (1) ti spiral blade 85mm for ti retrograde femoral nails-ex this is report 3 of 6 for complaint (b)(4).

• Brand Name: TI SPIRAL BLADE 85MM FOR TI RETROGRADE FEMORAL NAILS-EX
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11682383
• MDR Text Key: 261721955
• Report Number: 2939274-2021-01910
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982087522
• UDI-Public: (01)10886982087522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.013.049
• Device Catalogue Number: 04.013.049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 79