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

Model Number	2440-00-600
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary.Territory 230 reported that black portion on acetabular reamer broke at end closest to adapter junction.
Event or Problem Description
Complaint description: black portion on acetabular reamer broke at end closest to the adapter junction investigation method: the device associated with this report was not returned.The designed supplier reviewed the device history records and determined the device was manufactured out of the correct materials and to all print specifications.Reopened - product received.Investigation summary: territory 230 reports the black portion on acetabular reamer broke at end closest to the adapter junction.The device associated with this report was not returned.The designed supplier reviewed the device history records and determined the device was manufactured out of the correct materials and to all print specifications.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the investigation, the need for corrective action is not indicated.Reopened - product received.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error since it was found to be a product for resale.Depuy does not have the responsibility to make reportability determination and submit regulatory report.Supplier has been notified of the event.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• 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: 9845896
• Report Number: 1818910-2020-08393
• Device Sequence Number: 16334900
• Product Code: HTO
• UDI-Device Identifier: 10603295424307
• UDI-Public: 10603295424307
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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 Model Number: 2440-00-600
• Device Catalogue Number: 244000600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1