MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.3MM CANNULATED SCREW FULLY THREADED/80MM; SCREW, FIXATION, BONE

Model Number	209.680
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant device is not expected to be returned for manufacturer review/investigation.(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 a revision on (b)(6) 2017, due to pain.The device was not broken and was removed intact.The patient was initially implanted with a 7.3mm cannulated screw fully threaded/80mm in the left sacroiliac (si) joint on an unknown date.It was reported that the patient was revised to a similar item.Revision was completed successful with the patient in a stable condition.This report is for one (1) 7.3mm cannulated screw fully threaded/80mm this is report 1 of 1 for complaint (b)(4).

• Brand Name: 7.3MM CANNULATED SCREW FULLY THREADED/80MM
• 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: 7097670
• Report Number: 2939274-2017-50186
• Device Sequence Number: 11246198
• Product Code: HWC
• UDI-Device Identifier: 10886982150837
• UDI-Public: (01)10886982150837(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K962011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 209.680
• Device Catalogue Number: 209.680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• 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: 35 YR