MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG RIGHT CUT BLOCK; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

Model Number	2544-00-015
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the pin got jammed in right 0 degree cutting block causing pin to snap at the tip.Both parts retrieved.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation, however photo was provided for review.Review of the provided photo revealed that the fixation pin is jammed inside one of the holes of the cutting block and device shows signs of heavy usage, however no burrs inside the guide holes can be identified from the provided photo.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Additional information was received and stated that the issue was the rough inside surface of the drill hole of the cutting block.The pin was single-use.
Additional 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 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.

• Brand Name: ATTUNE 0 DEG RIGHT CUT BLOCK
• 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: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17071133
• Report Number: 1818910-2023-11663
• Device Sequence Number: 15138159
• Product Code: HTZ
• UDI-Device Identifier: 10603295421191
• UDI-Public: 10603295421191
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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: 2544-00-015
• Device Catalogue Number: 254400015
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 06/07/2023; 06/19/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 06/16/2023; 06/20/2023
• 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