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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US HP MBT CEM KEEL PUNCH SZ 2-3; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
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DEPUY ORTHOPAEDICS INC US HP MBT CEM KEEL PUNCH SZ 2-3; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET Back to Search Results
Catalog Number 950502011
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Broken metal at the punch-handle attachment.
 
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Brand Name
HP MBT CEM KEEL PUNCH SZ 2-3
Common Device Name
KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key8271350
Report Number1818910-2019-82011
Device Sequence Number11187291
Product Code LRY
UDI-Device Identifier10603295227311
UDI-Public10603295227311
Combination Product (Y/N)N
Initial Reporter CountryNO
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/03/2019
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
Operator of Device Health Professional
Device Catalogue Number950502011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/03/2019
Initial Report FDA Received Date01/23/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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