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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US CALCAR MILL HANDLE; HIP INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS INC US CALCAR MILL HANDLE; HIP INSTRUMENTS : HANDLES Back to Search Results
Model Number 2001-46-000
Device Problems Break (1069); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/19/2021
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
It was reported that the calcar reamer shaft is missing a washer where it connects to the disc.As a result, the reamer wobbles on the calcar.No surgical delay.
 
Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes considers the investigation closed at this time.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).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
CALCAR MILL HANDLE
Type of Device
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12252218
MDR Text Key264275194
Report Number1818910-2021-16570
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295079996
UDI-Public10603295079996
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 07/19/2021
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 Model Number2001-46-000
Device Catalogue Number200146000
Device Lot NumberAG2077611
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Initial Date Manufacturer Received 07/19/2021
Initial Date FDA Received07/30/2021
Supplement Dates Manufacturer Received08/03/2021
Supplement Dates FDA Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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