MAUDE Adverse Event Report: DEPUY MITEK LLC US RESTORE FULLFLUTE REAM 11MM EA; REAMER

Catalog Number	219341
Medical Device Problem Codes	Degraded (1153); Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.H11 additional narrative: investigation summary: according to the information received, it was reported that during the brocade of the tibia, a drill bit of 11.0 mm of tibia is used, reference restore fullflute ream 11mm ea, which is inefficient and the assistant specialist requires to exert more force to perform the tunnel.Once the cruciate ligament tunnels have been made, proceed to repair the meniscal root, pass the stitches through the meniscus and proceed to make the tibial tunnel to transport through it, the threads of the repair, which is done with previous position of the guide with eyelet and drilling with the 4.5mm rigidloop drill bit reference rigidloop reamer 4.5mm, of the same equipment through the tibia, in the same way, such drilling is inefficient, as well as the previous tunnel, when trying to pierce the second cortical, due to the force administered to the drill bit to be able to drill, there is a risk of, with the drill bit, tearing the stitches of the repair.The product has not returned to j&j medtech orthopaedics; however, a video was provided for review.Visual inspection of the returned video found that the reamer could be seen on the arthroscopic space.The device was connected to a power drill, the device appears to not be advancing when using the power tool.Based on the image provided is not possible to differentiate which of the devices is being used during the video provided.The overall complaint was confirmed as the observed condition of the restore fullflute ream 11mm ea would contribute to the complained device issue.¿ based on the investigation findings, a potential cause cannot be established.Multiple factors are associated with this type of failure, the complaint device needs to be physically evaluated in order to determine why the customer experienced the failure.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 j&j 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.
Event or Problem Description
It was reported that while performing an anterior cruciate ligament technique, during the brocade of the tibia, a drill bit device of tibia was used with the restore fullflute ream device which was inefficient and the assistant specialist had to exert more force to perform the tunnel and in turn.A lot of delay occurred during this step, the state of the motor and battery were verified to rule out failures of the power equipment.Satisfactory to the assessment in terms of force and speed, this being ruled out as causal.The process takes longer than usual to cross the metaphysis and effectively perforate the articular cortex of the tunnel, the tip of the buttonhole pin was protected with a curette, however, the force administered to be able to pierce the articular cortex must be so much that at the exit of the joint.It was impossible to control that the drill bit was not at the end of the joint.This is report 2 of 2 of (b)(4).
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, 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.

• Brand Name: RESTORE FULLFLUTE REAM 11MM EA
• Common Device Name: REAMER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21348814
• Report Number: 1221934-2025-00522
• Device Sequence Number: 7853895
• Product Code: HTO
• UDI-Device Identifier: 10886705005864
• UDI-Public: (01)10886705005864(10)1804547
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: 219341
• Device Lot Number: 1804547
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2018
• 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