MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 CAS LIGAMENT TENSOR SIZE 2-XF; KNEE INSTRUMENT: TENSIONING DEVICE

Catalog Number	129901080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11: additional narrative: h3, h6: the product was not returned to medtech orthopedics.However, photos were provided for review.Photos were provided for review.However, the photos only show part and lot number and no other observation pertaining to the nature of the reported event could be identified.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 photo was found scratched.The overall complaint was unconfirmed, as the photographs provided contained insufficient evidence of the reported event.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 medtech orthopedics 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.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 there was a sharp edge on the ligament tensor.The instrument was inspected outside of the theatre.There was no surgical delay.There were no patient consequences.

• Brand Name: CAS LIGAMENT TENSOR SIZE 2-XF
• Common Device Name: KNEE INSTRUMENT: TENSIONING DEVICE
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20879399
• Report Number: 1818910-2024-25053
• Device Sequence Number: 12716236
• Product Code: HWT
• UDI-Device Identifier: 10603295027072
• UDI-Public: (01)10603295027072(10)AB5368697
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 129901080
• Device Lot Number: AB5368697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• 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