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

Model Number 2544-01-014

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual examination of the returned device confirmed the reported damaged allegation.The device has two missing springs.Based on the damaged of the device, it is reasonable to conclude that the springs were damaged or presented a type of deformation that caused them to detached from the main device.However, the springs were not returned for evaluation therefore it is not possible to confirm the deformed allegation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the spring on the bottom of attune spacer block was damaged.Did not happen in surgery.

• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16658383
• MDR Text Key: 312492279
• Report Number: 1818910-2023-07116
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2023

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
• Device Operator: Health Professional
• Device Model Number: 2544-01-014
• Device Catalogue Number: 254401014
• Device Lot Number: BFA1P52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• 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