MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SELF-TAPPING 18MM; SCREW FIXATION INTRAOSSEOUS

Model Number	202.818
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code : hwc ktw.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 (b)(6) 2021, the patient underwent for a removal surgery.During the surgery, four (4) 2.7mm cortex screw self-tapping 16mm, two (2) 2.7mm cortex screw-tapping 18mm and one (1) 2.7mm lc-dcp plate 6 holes were removed due to pain.No fragments generated.There was no surgical delay.The procedure successfully completed.The patient outcome was unknown.This complaint seven (7) devices.This report is for (1) 2.7mm cortex screw self-tapping 18mm.This report is 7 of 7 (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SELF-TAPPING 18MM
• Common Device Name: SCREW FIXATION INTRAOSSEOUS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11709137
• Report Number: 2939274-2021-02025
• Device Sequence Number: 3894420
• Product Code: HWC
• UDI-Device Identifier: 10886982144751
• UDI-Public: (01)10886982144751
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2021

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: 202.818
• Device Catalogue Number: 202.818
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7MM CORTEX SCREW SELF-TAPPING 16MM; 2.7MM CORTEX SCREW SELF-TAPPING 16MM; 2.7MM CORTEX SCREW SELF-TAPPING 18MM; 2.7MM LC-DCP PLATE 6 HOLES/59MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 20 YR