MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; SCREW,FIXATION,BONE

Model Number	402.880
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s weight is unknown.Additional product device code: hrs.Device broke during insertion; device not considered implanted/explanted.Complainant device 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 on (b)(6) 2017 patient presented with failure of the talonavicular joint fusion.Date of the original surgery is unknown.It was identified that four (4) cannulated screws that were implanted within the patient were broken.Surgeon performed a revision surgery on (b)(6) 2017 to extract the broken screws and implant new devices.Patient was revised to new implants which included one (1) x-plate and four (4) titanium cortex screws.As the surgeon was tightening the last titanium screw, the head off the titanium cortex screw broke off.The threaded portion of the screw was left embedded in the patient while the head of the broken screw was removed.There were no issues noted with the screw driver.The revision surgery was completed without any surgical delay.The patient is reported to be in stable condition.This report addresses the intraoperative issue of a broken screw.The postoperative broken screws has been captured under linked (b)(4).Concomitant parts reported: unknown screw driver (part number unknown, lot number unknown, quantity 1).This report is for one (1) 2.7 mm ti cortex screw self-tapping with t8 stardrive recess 20 mm.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• 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: 7135541
• Report Number: 2939274-2017-50386
• Device Sequence Number: 1310547
• Product Code: HWC
• UDI-Device Identifier: 10886982206749
• UDI-Public: (01)10886982206749(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2017

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: 402.880
• Device Catalogue Number: 402.880
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR