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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 Device Slipped
Event Date 09/29/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Examination of the returned instrument confirmed the complaint. 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 ace reamer handle won't hold acetabulum reamers.

 
Manufacturer Narrative

Examination of the returned instrument confirmed the complaint. 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.

 
Manufacturer Narrative

Product complaint (b)(4). This product had been identified as a pfr. The responsibility to make a reporting determination and submit the adverse event reporting is the responsibility of the supplier.

 
Manufacturer Narrative

The correct date received by is 11/28/2018. This product had been identified as a pfr. The responsibility to make a reporting determination and submit the adverse event reporting is the responsibility of the supplier.

 
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Brand NamePINNACLE STRAIGHT GRATER HNDL
Type of DevicePROJECT 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 drive
in
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6103142063
MDR Report Key7907798
Report Number1818910-2018-70465
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type OTHER
Type of Report Initial,Followup,Followup,Followup
Report Date 09/05/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number244000600
Device LOT NumberSO2017262
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/13/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/25/2014
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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