MAUDE Adverse Event Report: SYNTHES GMBH UNIVERSAL JOINT ANGLED DRIVE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	SD03.617.902
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date instruments were stripped, broken and did not work.The drivers were stripped, an area of the angled driver where the joint was, flared out and did not allow the piece to work with other instruments.The tips of the driver and drill had also broken off.It observed during inspection of instruments.There was no patient involvement.No other information was provided.This report involves one (1) universal joint angled drive this is report 2 of 10 for (b)(4).
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.H3, h4, h6 investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot: the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.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.

• Brand Name: UNIVERSAL JOINT ANGLED DRIVE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19533039
• Report Number: 8030965-2024-07434
• Device Sequence Number: 7606259
• Product Code: OVE
• UDI-Device Identifier: 10705034701950
• UDI-Public: (01)10705034701950
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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: SD03.617.902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0MM DRILL BIT WITH 12MM STOP UNIVERSAL; 2.0MM DRILL BIT WITH 12MM STOP UNIVERSAL; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; INNER SHAFT FOR ANGLED SCREWDRIVER; UNIVERSAL JOINT ANGLED DRIVE
• Patient Sex: Unknown