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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIG HP FBT CEM KL PNCH SZ1.5-3; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET
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DEPUY ORTHOPAEDICS INC US SIG HP FBT CEM KL PNCH SZ1.5-3; KNEE INSTRUMENT : TIBIAL KEEL PUNCH/BULLET Back to Search Results
Catalog Number 950502047
Medical Device Problem Code Naturally Worn (2988)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint : (b)(4).Investigation summary : examination of the returned device found expected material wear.The wear is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action depuy synthes considers the investigation closed.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
It was reported that the office sets does not work.Device was found to have wear.
 
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Brand Name
SIG HP FBT CEM KL PNCH SZ1.5-3
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 Key8912306
Report Number1818910-2019-101746
Device Sequence Number11262819
Product Code LRY
UDI-Device Identifier10603295227632
UDI-Public10603295227632
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/07/2019
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 Number950502047
Device Lot NumberJ0808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/07/2019
Initial Report FDA Received Date08/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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