MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ADV+ CUFF GUIDE LT; SIZING/MEASURING INSTRUMENTS

Catalog Number	212862120
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When attempting to pin the anatomic resection guide, the legend ii fixation pin became stuck in the pin hole and was unable to be removed.The surgeon pinned the cutting guide using the remaining pinhole.There was no impact to the patient, and no delay to surgery.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary = > according to the information received, ¿when attempting to pin the anatomic resection guide - left (212862120) the legend ii fixation pin (249095000) became stuc in the pin hole and was unable to be removed.The surgeon pinned the cutting gudie using the remaining pinhole.¿ the product was not returned to depuy synthes, however photos were provided for review.See attachment ¿img_0545.Jpg¿.The investigation was not able to confirm the reported event as the complaint condition was not represented clearly in the provided photo.The provided evidence was not sufficient to confirm the reported event of jammed/seized and inability to disassemble.Functionality issues cannot be evaluated through a photo investigation.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.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 complaint condition.As part of depuy synthes 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 = > the device lot number is unknown, therefore a¿device history review could not be performed.¿ if the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ADV+ CUFF GUIDE LT
• Common Device Name: SIZING/MEASURING INSTRUMENTS
• 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 ; 3035526892
• MDR Report Key: 19929224
• Report Number: 1818910-2024-16978
• Device Sequence Number: 2846426
• Product Code: HTZ
• UDI-Device Identifier: 10603295089827
• UDI-Public: (01)10603295089827
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170748
• 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
• Report Date (Section B): 08/07/2024

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: 212862120
• 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: 08/04/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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