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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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DEPUY SYNTHES PRODUCTS LLC Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED Back to Search Results
Catalog Number 530.791
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported from (b)(6) that the brown liquid comes out of the quick coupling device after washing.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2020.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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 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.H10 additional narrative: the actual device was returned for evaluation.During evaluation it was determined that the reported condition was not confirmed.Therefore, the assignable root cause was not determined.However, during evaluation, it was determined that the device was difficult to assemble/disassemble due to component failure from normal wear.A device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.Corrected data, d10, the date the device was returned to the manufacturer was reported as february 25, 2020 in the initial report and has been updated to february 24, 2020.
 
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 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.Corrected data, d10, the date the device was returned to the manufacturer was reported as february 24, 2020 in the initial report and has been updated to february 25, 2020.
 
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Brand Name
Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM
Type of Device
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Manufacturer (Section D)
DEPUY SYNTHES PRODUCTS LLC
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9801929
MDR Text Key191834353
Report Number8030965-2020-01702
Device Sequence Number1
Product Code GEY
UDI-Device Identifier07611819491861
UDI-Public07611819491861
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number530.791
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Date Manufacturer Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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