MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW SHORT THREAD/18MM; SCREW, FIXATION, BONE

Model Number	207.618
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Irritation (1941)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Date of irritation is not known; date of implant is not known; device explant was not reported.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 the surgeon inquired as to the metal composition of the 4.0mm cannulated screw.The device was implanted on unknown date.Surgeon confirmed no allergic reaction to the device, but believes mechanical irritation from normal motion at the lisfranc¿s joint developed.It is not known if device was explanted.This report is for one (1) 4.0mm cannulated screw short thread 18mm this is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/18MM
• 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: 7487100
• Report Number: 2939274-2018-52025
• Device Sequence Number: 2053421
• Product Code: HWC
• UDI-Device Identifier: 10886982148094
• UDI-Public: (01)10886982148094
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 207.618
• Device Catalogue Number: 207.618
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/04/2018
• 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