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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCOPIC CANN DRILL BIT 7MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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SMITH & NEPHEW, INC. ENDOSCOPIC CANN DRILL BIT 7MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 013660
Device Problem Corroded (1131)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2019
Event Type  malfunction  
Event Description
It was reported a rust on the drill bit.No patient injuries or delay were reported as the failure was found after the surgery.
 
Manufacturer Narrative
Device has not been returned for examination, however a photograph was supplied.Review of the photograph confirmed the reported rusting like oxidation.The drills are water stained and contaminated with what appears to be human matter likely causing the observed oxidation.The most common cause of rust formation on stainless steel is improper cleaning.If the product is returned in the future the complaint can be reopened and evaluated.Initial reporter occupation: physician.
 
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Brand Name
ENDOSCOPIC CANN DRILL BIT 7MM
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
MDR Report Key8554845
MDR Text Key143410463
Report Number1219602-2019-00471
Device Sequence Number1
Product Code HWE
UDI-Device Identifier03596010091611
UDI-Public03596010091611
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number013660
Was Device Available for Evaluation? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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