MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 60MM; SCREW,FIXATION,BONE

Model Number	204.860
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
(b)(6).Date of postoperative pain development is unknown.Additional device product code: jds.Implanted on an unknown date.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 removal of one (1) 3.5 mm fully threaded cortex screw and one (1) 4.0 mm partially threaded cannulated screw on (b)(6) 2017 due to pain from their left ankle.The construct initially implanted on an unknown date included one (1) partially threaded 4.0 mm cannulated screw, one (1) 3.5 mm fully threaded cortex screw with an adjacent construct of one (1) unknown plate and unknown number of unknown screws.Both, the cannulated and the cortex screws were intact and no malfunctioned or deformities were observed on these screws.The plate and screw construct was described to be intact as well.Since the patient pinpointed the pain to the area where the cortex and cannulated screws were located, the surgeon decided to remove these two screws and associated them to be the reason for pain.The removal of the construct was conducted solely due to pain experienced by the patient.As per the surgeon, the patient will be fine.The removal procedure was completed successfully without any complications or surgical delay.Patient was not revised to another construct.This report is for one (1) 3.5 mm cortex screw self-tapping 60 mm.This is report 1 of 4 for complaint (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 60MM
• 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: 7195442
• Report Number: 2939274-2018-50285
• Device Sequence Number: 1174296
• Product Code: HWC
• UDI-Device Identifier: 10886982146502
• UDI-Public: (01)10886982146502(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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): 12/18/2017

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: 204.860
• Device Catalogue Number: 204.860
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/16/2018
• 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: 41 YR
• Patient Weight: 73