MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV TIB CEM CONICAL RMR; ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

Catalog Number	250620103
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms damage to the reamer.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 conical drills were getting hung up in the top of the drill towers and not passing through smoothly.The surgeon questioned wether any of the products were damaged or defective.No surgical delay.

• Brand Name: ATTUNE REV TIB CEM CONICAL RMR
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9272965
• Report Number: 1818910-2019-113818
• Device Sequence Number: 177671
• Product Code: HTO
• UDI-Device Identifier: 10603295440567
• UDI-Public: 10603295440567
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 09/05/2019

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: 250620103
• Device Lot Number: NG64617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1