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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD FLUSH CUTTER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
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SMITH & NEPHEW, INC. ACCORD FLUSH CUTTER; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL Back to Search Results
Catalog Number 71360024
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/06/2019
Event Type  malfunction  
Event Description
It was reported that during cutter would not cut, creating shards of cable in the wound.No injuries or delays reported.Backup device available.No more information provided yet.
 
Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re opened.
 
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Brand Name
ACCORD FLUSH CUTTER
Type of Device
PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8844193
MDR Text Key152748571
Report Number1020279-2019-02865
Device Sequence Number1
Product Code JDG
UDI-Device Identifier03596010485397
UDI-Public03596010485397
Combination Product (y/n)N
PMA/PMN Number
K123598
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/17/2019
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 Catalogue Number71360024
Device Lot Number09HM01328
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 07/06/2019
Initial Date FDA Received07/30/2019
Supplement Dates Manufacturer Received07/06/2019
Supplement Dates FDA Received11/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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