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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLENOID CANNULATED STOP DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES
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DEPUY IRELAND 9616671 GLENOID CANNULATED STOP DRILL; DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES Back to Search Results
Model Number 2307-89-000
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/02/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
While doing a shoulder arthroplasty, surgeon mentioned that the metaglene drill bit was dull.No patient harm.No surgery delay.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
GLENOID CANNULATED STOP DRILL
Type of Device
DRILLS (BITS, SLEEVES, GUIDES) : DRILL GUIDES
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key10706175
MDR Text Key212144555
Report Number1818910-2020-22873
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295116509
UDI-Public10603295116509
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2307-89-000
Device Catalogue Number230789000
Device Lot Number5233150
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/01/2020
Date Manufacturer Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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