MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM; SCREW, FIXATION, BONE

Model Number	02.211.026
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s identifier and weight are not available for reporting.Date of postoperative screw back out is unknown.Additional device product code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4) used to capture additional medical/surgical intervention required.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 underwent removal of two (2) midfoot/forefoot variable angle locking screws due to screws are backed out and are apparently visible.Procedure was completed without any complications and without any surgical delay.None of the pre, post or intra-operative x-rays from initial or revision surgery are available.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
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.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM
• 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: 7361913
• Report Number: 2939274-2018-51169
• Device Sequence Number: 1052358
• Product Code: HWC
• UDI-Device Identifier: 10886982053640
• UDI-Public: (01)10886982053640(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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,Followup
• Report Date (Section B): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.211.026
• Device Catalogue Number: 02.211.026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 03/22/2018
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention