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

Model Number 03.010.229

Device Problem Device-Device Incompatibility (2919)

Patient Problem Burn(s) (1757)

Event Date 02/20/2020

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) 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
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10065446
• MDR Text Key: 192029583
• Report Number: 2939274-2020-02373
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982068118
• UDI-Public: (01)10886982068118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.229
• Device Catalogue Number: 03.010.229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention