MAUDE Adverse Event Report: DEPUY SPINE INC T-HANDLE, RATCHETING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	299704135
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2023
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.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 on wednesday, october 18th, sets were dropped off for cases on friday, october 20th.Upon receipt of these sets, there were multiple instruments that were dubbed unfit to be used in surgery (part numbers of each instrument have been included).Spd ran a boroscope down each of the cannulated instruments (which we as reps do not have access to at any of our accounts to check these ourselves), and found multiple instruments that fell outside of their guidelines for safe use in surgery.Subsequently, i had to run to multiple different hospitals around denver to be able to make these sets complete and usable.This put me outside of the guidelines put in place by the va in terms of timeliness on dropping off the trays.Event occurred during sterile processing and field inspection.There were patient outcomes or consequences.One of the two cases scheduled had to be cancelled this report is for one (1) t-handle, ratcheting this is report 1 of 10 for complaint (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.The product was not returned to depuy synthes, however photos were provided for review.See attachment: the photo investigation did not revealed any defect with t-handle, ratcheting.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the t-handle, ratcheting would not contribute to the complained device issue.Based on the investigation findings, potential cause not established 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.A review of the receiving inspection (ri) for t-handle, ratcheting was conducted identifying that lot number: gb142123 was released in one batch.Batch1: lot units were released on 10 jun 2022 with no discrepancies.Supplier : depuy: gauthier biomedical, inc.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.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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned device found that the t-handle, ratcheting has signs of white foreign particles at the surface.It is unknown at this point in which part of the process this happened and the origin of these white particles.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the t-handle, ratcheting would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T-HANDLE, RATCHETING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18096867
• Report Number: 1526439-2023-02252
• Device Sequence Number: 6721561
• Product Code: LXH
• UDI-Device Identifier: 10705034467306
• UDI-Public: (01)10705034467306
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Physician
• Type of Report: Initial,Followup,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: 299704135
• Device Lot Number: GB142123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 12/27/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/04/2023; 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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: EXPED VERSE NAV DRIVER - SHAFT; PENCIL HANDLE; PENCIL HANDLE; PENCIL HANDLE; PENCIL HANDLE; PENCIL HANDLE; PENCIL HANDLE; TEAR-DROP HANDLE, RATCHETING; TEAR-DROP HANDLE, RATCHETING
• Patient Sex: Unknown