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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP FBT KEEL PUNCH IMPACT; KNEE INSTRUMENT : HANDLES
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DEPUY ORTHOPAEDICS INC US SIGMA HP FBT KEEL PUNCH IMPACT; KNEE INSTRUMENT : HANDLES Back to Search Results
Model Number 9505-02-055
Device Problems Structural Problem (2506); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2020
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 tibial impactor handle will not stay connected to the tibial punch upon removal.The locking mechanism has worn.
 
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
SIGMA HP FBT KEEL PUNCH IMPACT
Type of Device
KNEE INSTRUMENT : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11037633
MDR Text Key222629989
Report Number1818910-2020-27232
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295227717
UDI-Public10603295227717
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 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9505-02-055
Device Catalogue Number950502055
Device Lot NumberSO2044461
Was Device Available for Evaluation? No
Date Manufacturer Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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