MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	199721001
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
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.H11 additional narrative: b3: only event year is known.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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.H6 component code: g07002 (appropriate term/code not available) used to capture no findings available due to no product returned.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, during a spinal fusion (l4-s1 posterior lumbar fusion) the surgeon was using the expedium si final tightener with torque handle to lock off the sets screw on the construct.Both set screws got stripped.Replaced with new set screws and locked the construct off with the proper expedium verse final tightener and torque handle in set.There was no surgical delay.There were no patient consequences reported.The sales representative has spoken to surgeon regarding the use of the correct instrument.The tip of the expedium si despite being both x25 drivers, are more shallow hence why the driver will not engage with the set screw as well as the proper expedium verse x25 driver.More chance of the expedium si driver not engaging into the set screws and strips it down.This report involves one (1) expedium verse spine system unitized set screw 5.5.This is report 2 of 3 for (b)(4).

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 19324117
• Report Number: 1526439-2024-01464
• Device Sequence Number: 6680461
• Product Code: NKB
• UDI-Device Identifier: 10705034466156
• UDI-Public: 10705034466156
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K200245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 199721001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE UNITIZED SET SCR; TORQUE WRENCH; VERSE X25 INSERTER/TIGHTENER; X25 FINAL TIGHTENER; X25 FINAL TIGHTENER
• Patient Sex: Unknown