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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 1818910 TIBIAL RESECTION BLOCK 7 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
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DEPUY ORTHOPAEDICS INC US 1818910 TIBIAL RESECTION BLOCK 7 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 249256000
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2018
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
Pin could not be removed.
 
Manufacturer Narrative
Product complaint (b)(4).(b)(4) if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).Investigation summary
=
> examination of the returned device confirmed the reported 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
TIBIAL RESECTION BLOCK 7 DEG
Type of Device
KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8132598
MDR Text Key129457085
Report Number1818910-2018-77183
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K043223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number249256000
Device Lot NumberAH0199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Date Manufacturer Received01/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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