MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW; TRAY,SURGICAL INSTRUMENT

Model Number	387.34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
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) 2019, during a medial column fusion and tarsometatarsal tmt arthrodesis right foot.When inserting a 4.5 mm headless compression screw with power, the compression screw broke off at the tread shaft junction.The screw was under much torque when it broke.The surgeon spent 15 min trying to remove the screw but was not successful.1/2 the screw remains in the patient.In the process of removing the screw, the conical extraction device from screw removal set also broke.The very distal tip of this also remains in the patient.Additional fixation was implanted around the broken screw.The part of the screw that was removed and will not be returned.There were fragments generated and embedded in the patient's bone in the middle of the second metatarsal.There were a 15 minutes surgical delay.The procedure successfully completed.The patient outcome is unknown.This complaint involves one (1) device.This report is for one (1) conical extraction screw.This is report 1 of 1 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW
• Common Device Name: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9250562
• Report Number: 2939274-2019-61804
• Device Sequence Number: 2362643
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2019

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: 387.34
• Device Catalogue Number: 387.34
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR