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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC OVAL CURETTE ANGLED 6MM

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DEPUY SPINE INC OVAL CURETTE ANGLED 6MM Back to Search Results
Model Number 273509206
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Event Description
It was reported that during a procedure on (b)(6) 2022, the curette broke in half.Procedure was completed with no delay.There was no patient consequence.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: reporter is a synthes employee.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h6: a product investigation was conducted.The product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the handle of the oval curette angled 6mm was broken into two pieces.Both pieces were returned for evaluation.No other issues were identified.The dimensional inspection could not be performed due to the post manufacturing damage.The observed condition of the oval curette angled 6mm was consistent with a random component failure that may have been caused by exposure to excessive/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 oval curette angled 6mm was observed to have its handle broken into two pieces.While no definitive root cause could be determined from the available information, it is probable that the oval curette angled 6mm was broken due to the exposure to excessive/unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.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
OVAL CURETTE ANGLED 6MM
Type of Device
CURETTE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13863481
MDR Text Key288180453
Report Number1526439-2022-00442
Device Sequence Number1
Product Code HTF
UDI-Device Identifier10705034190471
UDI-Public(01)10705034190471
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number273509206
Device Catalogue Number273509206
Device Lot Number0106K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2022
Initial Date FDA Received03/23/2022
Supplement Dates Manufacturer Received04/20/2022
Supplement Dates FDA Received04/22/2022
Was Device Evaluated by Manufacturer? Yes
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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