MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS

Model Number 2544-01-014

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (b)(4).Investigation summary
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> examination of the returned device revealed a missing balseal spring on one of the 4 posts.The investigation findings did not indicate that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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 Description

The instrument was reported for an unknown reason.No surgical delay.

• Brand Name: ATTUNE SPACER BLOCK
• Type of Device: ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12267576
• MDR Text Key: 264764379
• Report Number: 1818910-2021-16826
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295395379
• UDI-Public: 10603295395379
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2544-01-014
• Device Catalogue Number: 254401014
• Device Lot Number: BFA1P72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1