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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC. CONFIDENCE KIT, NO NEEDLES; ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT

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DEPUY SPINE INC. CONFIDENCE KIT, NO NEEDLES; ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT Back to Search Results
Model Number 283913000
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
Event Type  malfunction  
Event Description
Device report from depuy synthes reports an event in (b)(6) as follows: it was reported by the customer in (b)(6) that during a spinal fusion surgery on (b)(6) 2022, it was observed that there was water leakage from the confidence system device at cement reservoir.According to the report, the cement augmentation on one vcffx screw could not be finished.Another like device was used to complete the procedure with a delay of 10 minutes.There were no adverse patient consequences reported.No additional information was provided.This report is for one (1) confidence kit, no needles device.This complaint involves 1 devices.
 
Manufacturer Narrative
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.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.
 
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.A manufacturing record evaluation was performed for the finished device product code: 283913000.Lot number: 324698.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 28.09.2021.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 there were no problems with the confidence kit, no needles.A dimensional inspection was unable to be performed due to device design.A functional test was performed to identify the water leakage.After turning the pump clockwise, no water leakage was observed on the cement reservoir.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the confidence kit, no needles would not 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.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
CONFIDENCE KIT, NO NEEDLES
Type of Device
ORTHOPAEDIC CEMENT PREPARATION/DELIVERY KIT
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 Key14205857
MDR Text Key290060373
Report Number1526439-2022-00608
Device Sequence Number1
Product Code NDN
UDI-Device Identifier10705034209630
UDI-Public10705034209630
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K060300
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
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
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283913000
Device Catalogue Number283913000
Device Lot Number324698
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
Patient SexMale
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