MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB CR ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS

Model Number 2545-00-524

Device Problem Use of Device Problem (1670)

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

Event Date 01/14/2021

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 during a routine inspection of one of the attune consignment instrumentation trays by sterile processing personnel, an attune cr femoral trial and an attune cr articular surface were found damaged.The femoral trial has a sizable gouge in the trochlear groove portion of the trail.The articular surface was found to be missing one of the two small springs that wraps around the shim connection posts.The whereabouts of the missing spring is unknown.No delay to surgery reported.

Manufacturer Narrative

Product complaint # : pc-(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 synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : examination of the returned device confirmed the reported event.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.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 lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FB CR ARTIC SURF SZ4
• Type of Device: ATTUNE INSTRUMENTS : TIBIAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11217665
• MDR Text Key: 228435432
• Report Number: 1818910-2021-01715
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295132646
• UDI-Public: 10603295132646
• 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: 01/14/2021

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: 2545-00-524
• Device Catalogue Number: 254500524
• Device Lot Number: MVMBKL140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 01/25/2021; 02/11/2021
• Supplement Dates FDA Received: 02/01/2021; 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1