MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP 7.0MM 30-70MM PLUS OR MINUS 1.33 PERCENT; TAP, BONE

Catalog Number	279702700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2023
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 not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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
It was reported that on september 16, 2023, the facility notified of instruments that had been broken or damaged.There was no patient involvement.Issues were discovered postoperatively.This report involves one expedium spine system double-lead tap 7.0mm 30-70mm plus or minus 1.33 percent.This is report 2 of 9 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.D4: lot # and expiration date added.H4: device manufacture date added.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this 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.H6: a review of the receiving inspection (ri) for 7mm dual-lead tap, was conducted identifying that lot number ng35121 was released in one batch.Batch1: lot qty of (b)(4) units were released on oct 3, 2012 with no discrepancies.Supplier : depuy : (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.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 sample revealed that 7mm dual-lead tap was found the device tip broken.The broken fragment was returned for evaluation.The allegation can be confirmed.A dimensional inspection for the 7mm dual-lead tap was not performed as it is not applicable to the complaint condition.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the 7mm dual-lead tap would 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 SPINE SYSTEM DOUBLE-LEAD TAP 7.0MM 30-70MM PLUS OR MINUS 1.33 PERCENT
• Common Device Name: TAP, BONE
• 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: 17875183
• Report Number: 1526439-2023-01916
• Device Sequence Number: 20606803
• Product Code: HWX
• UDI-Device Identifier: 10705034198651
• UDI-Public: (01)10705034198651
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,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: 279702700
• Device Lot Number: NG35121
• 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: 09/16/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 01/02/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2012
• 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