MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW-SHORT THREAD 68MM; SCREW,FIXATION,BONE

Model Number	207.668
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Implant and explant dates: device malfunctioned intraoperative.Device was not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 surgery for an open reduction internal fixation (orif) of the ankle.During the procedure, upon insertion of the screw, it was noted that a piece of screw had broken off in the patient.The screw was removed, but a small piece was unable to be retrieved and was left inside the bone.Patient outcome was reported as okay following the procedure.This report is for one (1) 4.0mm cannulated screw-short thread 68mm.This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM CANNULATED SCREW-SHORT THREAD 68MM
• 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: 7393157
• Report Number: 2939274-2018-51415
• Device Sequence Number: 16395757
• Product Code: HWC
• UDI-Device Identifier: 10886982148360
• UDI-Public: (01)10886982148360(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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: 207.668
• Device Catalogue Number: 207.668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1