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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 Detachment of Device or Device Component (2907); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2021
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 fixed bearing tibial punch handle is not functioning properly.The locking mechanism that holds the punch onto the handle has lost its rigidity and doesn¿t remove the punch when extracted.The punch comes off the handle.The instrument did not break, only the locking mechanism has loosened over time.No surgical delay.
 
Manufacturer Narrative
Product complaint # : (b)(4).Investigation summary : the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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
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 Key12211471
MDR Text Key262931354
Report Number1818910-2021-15756
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 06/30/2021
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 Number9505-02-055
Device Catalogue Number950502055
Device Lot NumberSO2044464
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/30/2021
Initial Date FDA Received07/22/2021
Supplement Dates Manufacturer Received08/17/2021
Supplement Dates FDA Received08/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age83 YR
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