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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS

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DEPUY ORTHOPAEDICS INC US SP*2 FEMORAL IMPACTOR; KNEE INSTRUMENT : IMPACTORS Back to Search Results
Model Number 96-6180
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2021
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 femur impactor tip is loose.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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Type of Device
KNEE INSTRUMENT : IMPACTORS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key12332893
MDR Text Key266950644
Report Number1818910-2021-18017
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295247203
UDI-Public10603295247203
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 08/04/2021
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 Number96-6180
Device Catalogue Number966180
Device Lot NumberSY0614
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/04/2021
Initial Date FDA Received08/17/2021
Supplement Dates Manufacturer Received09/14/2021
Supplement Dates FDA Received09/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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