MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 04.639.745

Device Problems Compatibility Problem (2960); Material Integrity Problem (2978)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: 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 Description

It was reported that on (b)(6) 2021, during a posterior spinal fusion, the matrix driver sleeve was jamming when removing the screw with two or three threads still threaded in the bone screw head.The screw was not loaded straight on the driver and was attempted to advance the sleeve either forward or backward without any movement.After the procedure ended, the bone screw was removed from the driver and after the threads was inspected, it appeared striped.Then the surgeon used a new screw and attempted to thread the driver sleeve into the bone screw.It jammed approximately 3/4 of the way threaded.When the surgeon went to remove the sleeve from the bone screw, the threads again jammed with approximately 1/4 of the threads to go.There was no surgical delay.The procedure was successfully completed.There was no patient consequences.This report is for one (1) 7.0mm ti matrix screw 45mm thread length this is report 2 of 3 for (b)(4).

• Brand Name: 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH
• 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): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 12414786
• MDR Text Key: 272911877
• Report Number: 2939274-2021-05134
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034749457
• UDI-Public: (01)10705034749457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.639.745
• Device Catalogue Number: 04.639.745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1