MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 8MM; SCREW,FIXATION,BONE

Model Number	401.158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date the patient was being tested for lichen planus and heard of titanium leaking from screws.The patient had 2.0mm cortex screws, self-tapping 8mm to 18mm length used to secure facial implant in mandible or midface from a previous surgery.Concomitant device: unknown plates: trauma (part# unknown, lot# unknwon, quantity# 1).This report is for one (1) 2.0mm ti mf cortex screw self-tapping w/flutes 8mm.This is report 3 of 4 for (b)(4).
Event or Problem Description
This is report 3 of 10 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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
Updated event description: it was reported that on an unknown date, the patient was being test for lichen planus and heard of titanium leaking from screws.The surgeon assumption was the 2.0mm cortex screws, self-tapping 8mm to 18mm length used to secure facial implant in mandible or midface.Upon notification from customer we went the route of medical information request thinking the patient was inquiring about a future surgery with titanium screws being implanted not knowing the patient already the screws implanted in a previous surgery.Concomitant device reported: unknown plates: trauma (part# unknown, lot# unknown, quantity# 1).This complaint involves ten (10) devices.

• Brand Name: 2.0MM TI MF CORTEX SCREW SELF-TAPPING W/FLUTES 8MM
• 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: 9997940
• Report Number: 2939274-2020-02044
• Device Sequence Number: 19953992
• Product Code: HWC
• UDI-Device Identifier: 20887587046256
• UDI-Public: 20887587046256
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2020

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: 401.158
• Device Catalogue Number: 401.158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2020
• Supplement Date Received by Manufacturer: 05/04/2020; 05/20/2020
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 05/18/2020; 05/26/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0MM TI MF CORTEX SCREW 10MM; 2.0MM TI MF CORTEX SCREW 12MM; 2.0MM TI MF CORTEX SCREW 6MM; 2.0MM TI MF CORTEX SCREW 8MM; UNK - PLATES; UNK - PLATES; UNK - PLATES; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - PLATES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 79