MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM TAB BREAKER, BODY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	299704310
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in united kingdom as follows: it was reported that they had an orthokit booking ref1010040401, using expedium verse.Whilst doing the final step of removing the tabs, a tab became lodged, stuck in the tab breaker, meaning it could no longer be used.An alternative tool was used to remove the tabs.There was no patient involvement.This report is for one (1) expedium tab breaker, body.This is report 1 of 1 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.H6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that a screw tab is inside the tip of the reported device.However, functionality of the device cannot be assessed through photo evidence provided.Appropriate use of the device diminishes the risk of failure; surgical technique for expedium verse spinal system was reviewed and the following relevant statement was found at page 34: this instrument has been designed to hold up to 40 tabs.The ¿full¿ line provides an indication as to when the reservoir must be emptied prior to proceeding.Additionally, a clearing boss has been provided on the inner side of tab breaker cap.This feature can be inserted into the distal end of the tab breaker to clear the last tab removed.It is recommended to keep the tabs in the reservoir from stacking against one another by occasionally shaking the tab breaker while moving from screw to screw.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the expedium tab breaker, body would not contribute to the complained device issue.Based on the investigation findings, 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 expedium tab breaker, body, was conducted identifying that lot number pu150988 was released in one batch.Batch1: lot units were released on nov 07, 2019 with no discrepancies.Supplier: (b)(4).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample found device was returned without evidence of tab stuck.Therefore, the investigation could not draw any conclusion of the reported event.Furthermore, spots of corrosion are observed on the surface and around the etch of the product code.Potential cause can be attributed to maintenance during cleaning or sterilization procedure; properly handling and maintenance to the approved use of the device diminishes the risk of failure.A dimensional inspection was performed for and met specifications.A functional test was unable to be performed without mating component.The overall complaint was unconfirmed as the observed condition of the expedium tab breaker, body would not contribute to the complained device issue.Based on the investigation findings, 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 reported 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: EXPEDIUM TAB BREAKER, BODY
• 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: 18923908
• Report Number: 1526439-2024-01072
• Device Sequence Number: 20380492
• Product Code: LXH
• UDI-Device Identifier: 10705034467375
• UDI-Public: (01)10705034467375
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 299704310
• Device Lot Number: PU150988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/29/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 04/03/2024; 04/22/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/03/2024; 04/03/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2017
• 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
• Patient Sex: Unknown