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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK DRILL; DRILLS
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DEPUY ORTHOPAEDICS INC US UNK DRILL; DRILLS Back to Search Results
Catalog Number UNK DRILL
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
Event Type  malfunction  
Manufacturer Narrative
(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
It was reported that the 3.2 drill bit got stuck in the distal femur cutting block.No delay to surgery 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
UNK DRILL
Type of Device
DRILLS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11282349
MDR Text Key230742404
Report Number1818910-2021-02445
Device Sequence Number1
Product Code HTO
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 01/22/2021
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 NumberUNK DRILL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/22/2021
Initial Date FDA Received02/04/2021
Supplement Dates Manufacturer Received03/15/2021
Supplement Dates FDA Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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