MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MON 5.5MM TRC W/BODY, 60MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number	177440060
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
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.Additional narrative: d2: additional procodes: kwp, mni.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.D9: complainant part is not expected to be returned for manufacturer.Review/investigation.E3: reporter is a synthes employee.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that patient underwent a spinal fusion (l5-il) for pelvic fracture on (b)(6) 2024.In the surgery, the set screw was stripped during placement and final fastening of the implant in question.A set screw of another size was used, but it too, was stripped.The final fastening was done with the third set screw.The surgery was completed successfully with no surgical delay.Patient was stable.This report is for a mon 5.5mm trc w/body, 60mm.This is report 1 of 2 for (b)(4).

• Brand Name: MON 5.5MM TRC W/BODY, 60MM
• Common Device Name: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19805947
• Report Number: 1526439-2024-01902
• Device Sequence Number: 18016597
• Product Code: MNH
• UDI-Device Identifier: 10705034061863
• UDI-Public: (01)10705034061863(11)170504(10)TI0725
• 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,Health Professional,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
• Operator of Device: Health Professional
• Device Catalogue Number: 177440060
• Device Lot Number: TI0725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown