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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC 4.35MM DOUBLE-LEAD TAP; TAP, BONE

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DEPUY SPINE INC 4.35MM DOUBLE-LEAD TAP; TAP, BONE Back to Search Results
Model Number 279702400
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/28/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in australia as follows: it was reported on (b)(6) 2022, that the surgeon was performing a l4-s1 posterior fusion and when he was using the 4.35mm tap on the 5th screw hole, the tap shaft broke just above the threaded portion.Surgeon was able use a bone ronguer to remove the broken off portion.This tap was placed to the side and after the case it was decontaminated in cssd and i collected it for return to the office when i am there next.There was no surgical delay.The procedure was successfully completed.No fragments were generated.Patient status/ outcome / consequences :no.This report is for one (1) 4.35mm double-lead tap this is report 1 of 1 for complaint (b)(4).
 
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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Part# 279702400.Lot # : 0108ng.Supplier: ng instr.Batch1: lot units were released on 06 feb 2008 with no discrepancies.No non-conformance reports were generated during production.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 photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment visual analysis of the photo revealed that 4.35mm double-lead tap was broken from the distal tip, the broken fragment is visible on the evidence provided.No other issues were found.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for 4.35mm double-lead tap.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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.
 
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.Part# 279702400.Lot # : 0108ng.Supplier: (b)(4).Batch1: lot units were released on 06 feb 2008 with no discrepancies.No non conformance reports were generated during production.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 4.35mm double-lead tap was broken from the threaded tip.The broken tip was returned for examination.No other issues were found.A dimensional inspection for the 4.35mm double-lead tap was not performed since is not applicable to the complaint condition.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 4.35mm double-lead tap would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: the following source controlled drawings reflecting the current and manufactured revisions were reviewed: -expedium double lead bone tap assemblies rev g/ rev d manufactured dimensional inspection: n/a.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.
 
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Brand Name
4.35MM DOUBLE-LEAD TAP
Type of Device
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 Key15995999
MDR Text Key308175202
Report Number1526439-2022-02144
Device Sequence Number1
Product Code HWX
UDI-Device Identifier10705034198590
UDI-Public(01)10705034198590
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
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
Device Operator Health Professional
Device Model Number279702400
Device Catalogue Number279702400
Device Lot Number0108NG
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/28/2022
Initial Date FDA Received12/16/2022
Supplement Dates Manufacturer Received02/01/2023
Supplement Dates FDA Received02/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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