MAUDE Adverse Event Report: DEPUY SPINE INC VERSE CORRECTION KEY; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Model Number 199721000

Device Problem Material Twisted/Bent (2981)

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

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Additional product code: osh, kwq, mni, nkb, kwp.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the outer locking of the verse correction key on all verse screws with final torque and quick sticks and counter holder.The correction manoeuvre was performed, in the inner set screw of the correction key was finally fixed with viper torque shaft, green torque handle, quick stick and counter holder.During this final tightening, it became apparent that the inner set screw on the right-hand th5 and the left-hand th2 the respective verse screw could not be finally tightened and did not release but "slipped".The correction keys were removed from the two screws and half-round metal chips appeared on the verse screw.Apparently, the thread of the respective verse screw was no longer in order.Two new correction keys were opened and placed back into the respective verse screw via quick stick.Fixed the outer set screw with torque and during the final fixing of torque the shaft did not click.Procedure was completed successfully with ten(10) minutes delay.There is no allegation against the instruments.Concomitant device reported: viper torque shaft (part# 286745550, lot# unknown, quantity unknown).Green torque handle (part# 286745500, lot# unknown, quantity unknown).Verse di inserter/fixer (part# 299704220, lot# unknown, quantity unknown).Handle f.Torque (part# 299704320, lot# unknown, quantity unknown).Quick sticks (part# 299704215, lot# unknown, quantity unknown).Counterholder (part# 299704255, lot# unknown, quantity unknown).Verse quick stick, tube(part# 299704217, lot# unknown, quantity unknown).This report is for one (1) expedium verse spine system verse correction key 5.5.This is report 3 of 4 for complaint (b)(4).

• Brand Name: VERSE CORRECTION KEY
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12661612
• MDR Text Key: 277399168
• Report Number: 1526439-2021-02213
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034466132
• UDI-Public: (01)10705034466132
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• 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