MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE BAL BLK SIZE 4; SPACER BLOCKS/TRIAL SHIMS

Model Number 2545-05-504

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It was reported that the attune blocks will not allow a balancing block knob to slide thru the top of them.Attempts were made with 3 different instrument trays all of the same lot numbers (3 sz 6 and 3 sz 4) and they all will not allow the same knob to pass thru the top of the block.Tried a different knob and they all was fine.Not sure if it is a knob or a block issue.No product or lot on the knobs.Issue found at warehouse, not in a case.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the balance block was not received for examination, therefore the reported event could not be confirmed.Depuy 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.

• Brand Name: ATTUNE BAL BLK SIZE 4
• Type of Device: SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10855559
• MDR Text Key: 216941937
• Report Number: 1818910-2020-24867
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295481720
• UDI-Public: 10603295481720
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2545-05-504
• Device Catalogue Number: 254505504
• Device Lot Number: OM10439
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1