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

Catalog Number	244000600
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the ace reamer handle won't hold acetabulum reamers.
Additional 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.
Additional 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.
Additional 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.

• Brand Name: PINNACLE STRAIGHT GRATER HNDL
• Common Device Name: PROJECT NEPTUNE : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 7907798
• Report Number: 1818910-2018-70465
• Device Sequence Number: 19400469
• Product Code: HTO
• UDI-Device Identifier: 10603295424307
• UDI-Public: 10603295424307
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 244000600
• Device Lot Number: SO2017262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018; 11/28/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 09/26/2018; 11/30/2018; 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR