MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE ADJ TIB STYLUS; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES

Model Number 2544-00-007

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2020

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.

Event Description

During training with surgeons earlier this week, wednesday 16 september at 12.00 it was noted that attune tibia stylus art nr 254400007 lot nw207641 was not functioning ¿ looks bent and is not able to put in to the cuttingblocks without getting stuck.This is a new instrument, never been used before, has been cleaned and sterilized by the hospital (b)(6).Delivered to the hospital 14 september.The instrument has been replaced with a new one.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: examination of the returned device did not confirm the reported event.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE ADJ TIB STYLUS
• Type of Device: ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10602680
• MDR Text Key: 209391829
• Report Number: 1818910-2020-21172
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295129790
• UDI-Public: 10603295129790
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-00-007
• Device Catalogue Number: 254400007
• Device Lot Number: NW207641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1