MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13MM PROTECTION SLEEVE-SHORT; MISC ORTHO SURGICAL INSTR

Model Number	03.010.229
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/20/2020
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) 2020, during femur nail using expert retrograde/ antegrade femoral nail (rafn) instruments.The surgeon kept pushing the drill bit and it heated up the protection sleeve and burned the skin.Both instruments were functioning normally and have been used since the procedure.There was no surgical delay reported.The procedure was successfully completed.Patient outcome bone fixation proceeded as planned, but the patient had skin burn which was treated and healed as planned.Concomitant devices reported: 13.0mm cannulated drill bit 300mm (part number 351.27, lot unknown, quantity 1).This report involves one (1) 13mm protection sleeve-short.This is report 2 of 2 for (b)(4).

• Brand Name: 13MM PROTECTION SLEEVE-SHORT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10065446
• Report Number: 2939274-2020-02373
• Device Sequence Number: 10954126
• Product Code: LXH
• UDI-Device Identifier: 10886982068118
• UDI-Public: (01)10886982068118
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: 03.010.229
• Device Catalogue Number: 03.010.229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention