MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS; MISC ORTHO SURGICAL INSTR

Model Number	03.025.040
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/07/2020
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, the patient underwent a femur fracture procedure using retrograde femoral nail.During the procedure, an incorrect protection sleeve was used and the screws missed the nail leaving a small hole in the nail.The screws were removed.The surgeon inserted the correct protection sleeve, drilled and inserted screws.There was a five (5) minute surgical delay.The procedure outcome is unknown.There was no patient harm.This complaint involves four (4) devices.This report is for one (1) 11.0mm/8.0mm protection sleeve 188mm for asls.This is report 1 of 3 for (b)(4).

• Brand Name: 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS
• 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: 10171981
• Report Number: 2939274-2020-02893
• Device Sequence Number: 13893773
• Product Code: LXH
• UDI-Device Identifier: 10886982069900
• UDI-Public: (01)10886982069900
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 03.025.040
• Device Catalogue Number: 03.025.040
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2020
• Initial Report FDA Received Date: 06/18/2020
• 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