MAUDE Adverse Event Report: DEPUY SPINE INC TELIGEN TABLE MOUNT ADAPTER KNOB; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL

Catalog Number	286001131
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date, that both the teligen table mount adaptor knob and teligen table mount adaptor fork were not functioning as they should.The knob is unable to tighten down and effectively capture the teligen port holder.There were no patient consequences reported.This report involves one teligen table mount adapter knob.This is report 1 of 2 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.H10 additional narrative: b3: only the event year is known.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j 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.
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.H10 additional narrative: h3, h6: a review of the receiving inspection (ri) for table mount adapter screw was conducted identifying that lot number 286001131 was released in two batch.-batch1: lot qty of 25 units were released on 01 dec 2022 with no discrepancies.Supplier : depuy : viant medical, llc - fort wayne -batch2: lot qty of 25 units were released on 01 dec 2022 with no discrepancies.Supplier : depuy : viant medical, llc - fort wayne as a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation did not reveal any evidence to confirm the unable to assemble condition of the device 286001131, table mount adapter screw since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the device (b)(6), table mount adapter screw would not contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: TELIGEN TABLE MOUNT ADAPTER KNOB
• Common Device Name: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17887018
• Report Number: 1526439-2023-01944
• Device Sequence Number: 7289581
• Product Code: JEB
• UDI-Device Identifier: 10705034560519
• UDI-Public: (01)10705034560519
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup

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: 286001131
• Device Lot Number: PC5305388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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: TABLE MOUNT ADAPTER FORK.
• Patient Sex: Unknown