MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM SETSCREW EXTRACTOR; MISC ORTHO SURGICAL INSTR

Catalog Number	03.611.031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient, with adjacent level disc disease, underwent a spine revision procedure on (b)(6) 2018, to remove synthes uss (universal spinal system) pedicle screws as the original level l5 - s1 had fused.The surgeon revised the patient to extend fusion one level above the already fused l5-s1 level.While the surgeon was attempting to back out the pedicle screw with general screw removal instruments, the tip of a 2.5mm set screw extractor broke off in the pedicle screw.The surgeon was able to remove the screw with vice grips without any additional medical intervention being required.The surgeon removed the 6.0mm titanium side-opening screw 45 mm (x2) and the 6.0mm titanium side-opening screws 50mm (x2).The explanted screws were discarded.All fragments were successfully removed and the patient outcome was reported to be "good" at the end of the procedure.Concomitant devices reported: 6.0mm titanium side-opening screw 45mm (part# 498.645, lot# unknown, quantity# 2), 6.0 mm titanium side-opening screw 50mm (part# 498.650, lot# unknown, quantity# 2).This report captures intraoperative breakage of set screw extractor.This report is for one (1) 2.5mm set screw extractor.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.5MM SETSCREW EXTRACTOR
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7927722
• Report Number: 2939274-2018-54088
• Device Sequence Number: 2269922
• Product Code: LXH
• UDI-Device Identifier: 10705034713847
• UDI-Public: (01)10705034713847
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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 Catalogue Number: 03.611.031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR