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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP POWER PIN DRIVER; KNEE INSTRUMENT : INSERTION DEVICES
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DEPUY ORTHOPAEDICS INC US HP POWER PIN DRIVER; KNEE INSTRUMENT : INSERTION DEVICES Back to Search Results
Model Number 9505-02-071
Device Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 07/21/2020
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 pin drivers are bent and not fitting pins.Spacer block spring is broken.
 
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
HP POWER PIN DRIVER
Type of Device
KNEE INSTRUMENT : INSERTION DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10339933
MDR Text Key200853366
Report Number1818910-2020-17169
Device Sequence Number1
Product Code HWE
UDI-Device Identifier10603295227878
UDI-Public10603295227878
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 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9505-02-071
Device Catalogue Number950502071
Was Device Available for Evaluation? No
Date Manufacturer Received07/31/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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