MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE NOTCH GUIDE SZ 10; RESECTION BLOCKS/DEVICES

Catalog Number	254500030
Medical Device Problem Codes	Break (1069); Material Discolored (1170); Illegible Information (4050)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the instrument broke.Illegible etching due to discoloration.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, it has been determined that there is no allegation against the device, no reportable event.Further updates will only be provided if additional information is received that changes the regulatory determination.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: instruments that lose color.Instrument lost color coding on size.The product was returned to medtech orthopaedics for evaluation.Visual inspection revealed the white ink backfilled into the debossed markings on the device were worn and missing.Additionally, device exhibits signs of usage.The previous investigations found the ink appearing to have been removed as a result of autoclave cycling due to multiple uses.Since the ink is backfilled into debossed marking, even if the ink is removed, the number markings remain, and are usable for the surgeon, though with a lower contrast.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune notch guide sz 10 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : quantity manufactured: (b)(4).Date of manufacture: 10/27/2020.Any anomalies or deviations identified in dhr: no.Expiry date: n/a.Ifu reference: ifu-0902-00-836.

• Brand Name: ATTUNE NOTCH GUIDE SZ 10
• Common Device Name: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19624427
• Report Number: 1818910-2024-14100
• Device Sequence Number: 17732328
• Product Code: HTZ
• UDI-Device Identifier: 10603295130475
• UDI-Public: (01)10603295130475(10)PG307416
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140881
• 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): 06/27/2024

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 Catalogue Number: 254500030
• Device Lot Number: PG307416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/01/2024; 09/17/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/08/2024; 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2020
• 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