MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE A-P CHAMFER BLOCK SZ 4; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	2545-00-154
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the instruments were discovered as damaged, cracked, missing springs and a metal burr in the cutting block saw capture.There was no surgical delay.
Additional 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.
Additional Manufacturer Narrative
Product complaint # = > (b)(4)this is a duplicate report of 1818910-2022-04629.1818910-2022-04645 is being retracted as it is a report duplication.1818910-2022-04629 will be kept for investigation purposes.H6.

• Brand Name: ATTUNE A-P CHAMFER BLOCK SZ 4
• Common Device Name: ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13769066
• Report Number: 1818910-2022-04645
• Device Sequence Number: 4104542
• Product Code: HTZ
• UDI-Device Identifier: 10603295395270
• UDI-Public: 10603295395270
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: 2545-00-154
• Device Catalogue Number: 254500154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown