MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE A-P CHAMFER BLOCK SZ 8; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number 2545-00-158

Device Problems Device-Device Incompatibility (2919); Scratched Material (3020)

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

Event Date 01/01/2021

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 the saw blade does not go through the cutting slots.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination and functional testing of the returned device was unable to identify a product defect.It should be noted the product returned without an alleged deficiency.Depuy considers the investigation closed at this time.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.H10 additional narrative: expiration date that was reported in d4 in the initial mw is now being retracted as instruments do not have expiration dates.

• Brand Name: ATTUNE A-P CHAMFER BLOCK SZ 8
• Type of Device: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12487908
• MDR Text Key: 271894818
• Report Number: 1818910-2021-20398
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295395317
• UDI-Public: 10603295395317
• 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
• Report Date: 08/27/2021

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: 2545-00-158
• Device Catalogue Number: 254500158
• Device Lot Number: PG224003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1