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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC CALIBRATED PAT CUT GDE; KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS

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DEPUY ORTHOPAEDICS INC US PFC CALIBRATED PAT CUT GDE; KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS Back to Search Results
Model Number 86-5034
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
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 sigma patella cut guide was broken, the saw capture broke free on one side.All pieces were removed.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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
PFC CALIBRATED PAT CUT GDE
Type of Device
KNEE INSTRUMENT : PATELLA HANDLE/CLAMPS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11006636
MDR Text Key221547551
Report Number1818910-2020-26922
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295216599
UDI-Public10603295216599
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 11/27/2020
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 Number86-5034
Device Catalogue Number865034
Device Lot NumberSO2022805
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/27/2020
Initial Date FDA Received12/15/2020
Supplement Dates Manufacturer Received01/14/2021
Supplement Dates FDA Received01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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