MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 80MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number 204.880

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional product code hrs hwc.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 product was received; no conclusion could be drawn at the time of filing 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 Description

It was reported that on (b)(6) 2021 the surgeon was removing a plate and 9 screws from this patient.During the removal 3 of the 3.5mm screw heads broke off into the patient.These 3 screws remained in the patient.He also removed a plate and 6 screws all of which were removed successfully.Procedure was completed successfully.It is unknown if there were fragments generated.It is unknown if there were surgical delay and patient consequence.This complaint involves ten (10) devices.This report is for (1) 3.5mm cortex screw self-tapping 80mm.This is report 6 of 10 (b)(4).Related product complaint: (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 80MM
• Type of Device: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11274491
• MDR Text Key: 230122183
• Report Number: 2939274-2021-00656
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 10886982146588
• UDI-Public: (01)10886982146588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 204.880
• Device Catalogue Number: 204.88
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.4MM CRTX SCRW 3.5MM HEAD/SLF-TPNG 40MM; 3.5MM CORTEX SCREW SELF-TAPPING 40MM; 3.5MM CORTEX SCREW SELF-TAPPING 80MM; 3.5MM TI CORTEX SCREW SELF-TAPPING/80MM; 3.5MM TI CORTEX SCREW SELF-TAPPING/80MM; 3.5MM VA-LCP PRX TBIA PLT SM BND/6H/117MM/LFT; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM; 3.5MM VBLE ANG LKNG SRW/SLF-TPN/STDRV/75MM
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR