MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP PS ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-545

Device Problems Break (1069); Crack (1135)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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 these instruments broke in surgery.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.Added: b5, h6 medical device problem code.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that they all broke into 2 pieces.The trials broke across the middle, creating a crack.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will bereviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ATTUNE RP PS ARTIC SURF SZ5
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12468027
• MDR Text Key: 271285591
• Report Number: 1818910-2021-20031
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295132851
• UDI-Public: 10603295132851
• 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: 08/23/2021

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: 2545-00-545
• Device Catalogue Number: 254500545
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 09/02/2021; 10/19/2021
• Supplement Dates FDA Received: 09/21/2021; 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1