MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SHIM SZ7 6MM; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-672

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

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

Event Date 04/15/2021

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 spring is damaged on shim and articulating surface.The spring was coming off/mal aligned.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE SHIM SZ7 6MM
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11759928
• MDR Text Key: 248430958
• Report Number: 1818910-2021-09396
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295133544
• UDI-Public: 10603295133544
• 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: 04/15/2021

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: 2545-00-672
• Device Catalogue Number: 254500672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/03/2021
• Supplement Dates Manufacturer Received: 05/27/2021; 06/11/2021
• Supplement Dates FDA Received: 06/08/2021; 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1