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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• 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: 11682383
• Report Number: 2939274-2021-01910
• Device Sequence Number: 14240393
• Product Code: HSB
• UDI-Device Identifier: 10886982087522
• UDI-Public: (01)10886982087522
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.013.049
• Device Catalogue Number: 04.013.049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/16/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79