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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RASP; ATTUNE INSTRUMENTS : CUTTING INSTRUMENTS
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DEPUY IRELAND - 9616671 ATTUNE RASP; ATTUNE INSTRUMENTS : CUTTING INSTRUMENTS Back to Search Results
Model Number 2545-00-048
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
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
Rasp, tibial & femoral impactor, 49 mm grater broken.No patient consequences or surgical delays reported.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE RASP
Type of Device
ATTUNE INSTRUMENTS : CUTTING INSTRUMENTS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11213152
MDR Text Key228172107
Report Number1818910-2021-01658
Device Sequence Number1
Product Code HTR
UDI-Device Identifier10603295130550
UDI-Public10603295130550
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2545-00-048
Device Catalogue Number254500048
Was Device Available for Evaluation? No
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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