MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM ANGLED AWL; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	03.617.993
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Additional procode: ove.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 during an anterior cervical discectomy procedure on an unknown date, the angled stardrive screwdriver and the 2.0mm angled awl were not adequate to properly create a screw path and insert the screw.The procedure was successfully completed with 5 minutes surgical delay.Patient status is unknown.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This complaint involves 2 devices.This report is for 1 description of part.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM ANGLED AWL
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10276156
• Report Number: 2939274-2020-03214
• Device Sequence Number: 14106715
• Product Code: KWQ
• UDI-Device Identifier: 10705034717401
• UDI-Public: (01)10705034717401
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• 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): 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.617.993
• Device Catalogue Number: 03.617.993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE; UNK - SCREWS