MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MONARCH SPINE SYSTEM ROD WITH VHG BODY 5.5 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	177440040
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product codes: mnh and kwp.Initial reporter is a depuysynthes sales representative.Part 177440040, lot ti1022: a manufacturing record evaluation was performed for the finished device and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on april 27, 2021.A product investigation was completed: visual analysis of the returned sample revealed that the recess of the screw component of the rod appears to be stripped.No other product problems identified.A dimensional inspection was unable to be performed due to device design.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.The current and manufactured to drawings were reviewed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during a plif (the lumbosacral transitional vertebrae) for the treatment lss and sacrum spine facture, the surgeon tried to tighten the rod connector with the setscrew, the setscrew was stripped.Another device was used to complete the procedure.The procedure was completed less than 30-minute surgical delay.The procedure was successfully completed.This report is for a monarch spine system rod.This report is for a this is report 3 of 3 for (b)(4).

• Brand Name: MONARCH SPINE SYSTEM ROD WITH VHG BODY 5.5 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14643163
• Report Number: 1526439-2022-00817
• Device Sequence Number: 5514388
• Product Code: MNI
• UDI-Device Identifier: 10705034061856
• UDI-Public: (01)10705034061856
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K024348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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
• Device Model Number: 177440040
• Device Catalogue Number: 177440040
• Device Lot Number: TI1022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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: MON 5.5MM TRC BODY; UNKNOWN LOCKING/SET SCREWS
• Patient Sex: Unknown