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

Model Number 2440-00-600

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

Event Type  malfunction  

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 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.

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
• Type of Device: PROJECT NEPTUNE : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9845896
• MDR Text Key: 220915687
• Report Number: 1818910-2020-08393
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295424307
• UDI-Public: 10603295424307
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1