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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US APG+ QC PERIPH BIT; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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DEPUY ORTHOPAEDICS INC US APG+ QC PERIPH BIT; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Model Number 2230-00-095
Device Problems Component Missing (2306); Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2020
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
Drill bit dull and back up missing.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.
 
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Brand Name
APG+ QC PERIPH BIT
Type of Device
DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10181169
MDR Text Key196010965
Report Number1818910-2020-14248
Device Sequence Number1
Product Code HTW
UDI-Device Identifier10603295103455
UDI-Public10603295103455
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 06/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2230-00-095
Device Catalogue Number223000095
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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