MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM CORTEX SCREW SELF-TAPPING 34MM; SCREW, FIXATION, BONE

Model Number	214.834
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an unknown date in (b)(6) 2018.Additional device product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: date of concomitant therapy is the same as date of implantation, an unknown date in (b)(6) 2018.Occupation: reporter is a synthes employee.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) 2018, patient underwent an unknown surgery.The variable angle locking compression plate (va-lcp) curved condylar plate was attached to an aiming arm.While the surgeon was attempting to attach percutaneous trocar to the jig, the aiming arm fell off the plate.This occurred a few times during the case until the jig was no longer able to grab the plate; presumably the hole in the plate was stripped out.Upon pulling the plate, the head of a cortex screw self-tapping broke off.They were able to retrieve the screw fragment in the medullary canal with some difficulty.A new, longer plate was placed and no other problems occurred.Procedure outcome is unknown.There was no patient consequence.Concomitant devices: trocar instrument (part: unknown, lot: unknown, quantity: 1), insertion handle (part: unknown, lot: unknown, quantity: 1), aiming arm (part: unknown, lot: unknown, quantity: 1).This report is for a 4.5mm cortex screw self-tapping 34mm.This is report 2 of 2 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 34MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8139338
• Report Number: 2939274-2018-55313
• Device Sequence Number: 19227361
• Product Code: HWC
• UDI-Device Identifier: 10886982154668
• UDI-Public: (01)10886982154668
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2018

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: 214.834
• Device Catalogue Number: 214.834
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2018
• Initial Report FDA Received Date: 12/06/2018
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 60