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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE STRAIGHT GRATER HNDL; PROJECT NEPTUNE : REAMERS

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DEPUY ORTHOPAEDICS INC US PINNACLE STRAIGHT GRATER HNDL; PROJECT NEPTUNE : REAMERS Back to Search Results
Catalog Number 244000600
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/02/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Examination of the returned instrument by the supplier confirmed the reported observation.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 Description
It was reported that the plastic sleeve cracked on the reamer handle.
 
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Brand Name
PINNACLE STRAIGHT GRATER HNDL
Type of Device
PROJECT NEPTUNE : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6107428552
MDR Report Key8095477
MDR Text Key128070137
Report Number1818910-2018-76185
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295424307
UDI-Public10603295424307
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 11/20/2018
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 Catalogue Number244000600
Device Lot NumberSO2019889
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/20/2018
Initial Date FDA Received11/21/2018
Date Device Manufactured07/21/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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