MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIBIAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS

Model Number 2544-01-003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the investigation identified the reported device was broken.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The attune fb tibial impactor was reported with unknown reason.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the investigation identified the reported device was broken.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint (b)(4).Investigation summary: update 03-feb-2021, the investigation was re-opened upon receipt of additional information.Examination of the returned device, found that the impactor was broken.Root cause and corrective action are documented in the capa system.Depuy synthes considers, the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot
=
> the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.Corrected: g1, h3.

• Brand Name: ATTUNE FB TIBIAL IMPACTOR
• Type of Device: ATTUNE INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8202430
• MDR Text Key: 131598105
• Report Number: 1818910-2018-79341
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295130192
• UDI-Public: 10603295130192
• 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,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-01-003
• Device Catalogue Number: 254401003
• Device Lot Number: AU3713549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR