MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-546

Device Problem Material Integrity Problem (2978)

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

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary :the device associated with this report was returned for analysis.Examination of the physical product can confirm the complaint.The post is broken from the device.The post and the spring were not returned for evaluation.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

It was reported that upon extracting the size 6 rotating platform ps trial surface, one of the posts on the bottom was damaged, rendering it unusable.All pieces were removed from the sterile field and accounted for, there was no injury to the patient or delay to the case.I have no further information on this situation.

• Brand Name: ATTUNE RP PS ARTIC SURF SZ6
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14395706
• MDR Text Key: 291618293
• Report Number: 1818910-2022-08833
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295132868
• UDI-Public: 10603295132868
• 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: 05/13/2022

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: 2545-00-546
• Device Catalogue Number: 254500546
• Device Lot Number: MVMBRB410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• 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