MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VA LOCKING DOUBLE DRILL GUIDE/FREEHAND F/2.0 VAL PL; APPLIANCE FIXATION SPINAL INTERLAMINAL

Model Number	03.130.321
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 as no product was received.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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 an unknown date, the variable angle portion of the drill guide is bent and crushed in a manner that it cannot pass a drill bit through or be repaired.Procedure and patient involvement were unknown.Concomitant device reported: unknown drill bit (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 1.5MM VA LOCKING DOUBLE DRILL GUIDE/FREEHAND F/2.0 VAL PL
• Common Device Name: APPLIANCE FIXATION SPINAL INTERLAMINAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9751641
• Report Number: 2939274-2020-01046
• Device Sequence Number: 727504
• Product Code: NKB
• UDI-Device Identifier: 10886982075642
• UDI-Public: (01)10886982075642
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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: 03.130.321
• Device Catalogue Number: 03.130.321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1