MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI CANNULATED SCREW LONG THREAD/40MM; SCREW, FIXATION, BONE

Model Number	407.740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient identifier and weight not available for reporting.Date reported is (b)(6) 2018, exact date is not known.It is not known if device was implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Facility telephone not available for reporting.(b)(4).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 a patient underwent an unknown revision procedure utilizing a 4.0mm ti cannulated screw long thread/40mm which was discarded.It was also reported that there was no device malfunction and the reason for the revision remains unknown.Patient consequence is unknown.The surgery was completed successfully and there was no surgical delay.It was also reported that there were no other medical intervention required.This report is for one (1) 4.0mm titanium cannulated screw.(b)(4).

• Brand Name: 4.0MM TI CANNULATED SCREW LONG THREAD/40MM
• 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: 7400662
• Report Number: 2939274-2018-51476
• Device Sequence Number: 13746449
• Product Code: HWC
• UDI-Device Identifier: 10886982208699
• UDI-Public: (01)10886982208699(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• 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): 03/13/2018

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: 407.740
• Device Catalogue Number: 407.740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• 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
• Patient Age: 16 YR