MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL SHAVER HANDPIECE 2.0 WITH BUTTONS; ARTHROSCOPE

Catalog Number 283812

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

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 mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

Report 1 of 2 of (b)(4).It was reported by the sales rep in switzerland that during a knee surgery on (b)(6) 2023, when the surgeon was shavering the tissue in the joint with the shaver handpiece 2.0 with buttons device, a black liquid came out of the suction tubing from the shaver handpiece device.It was reported that nothing was visible in the joint, only in the shaver outflow tubing and the scrub nurse thought first it was oil from the shaver handpiece device but the liquid was not floating on the waste bin so she wasn't sure what it was exactly.There was a four minute delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.

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 mitek or its employees that the report constitutes an admission that the device, 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.H10 additional narrative: the investigation has been updated to reflect the correct information: investigation summary according to the information received, it was reported that the surgeon was shavering the tissue in the joint as suddenly a black liquid came out of the suction tubing from the shaver handpiece.Nothing was visible in the joint, only in the shaver outflow tubing.The scrub nurse thought first it was oil from the shaver handpiece but the liquid was not floating on the waste bin.So she wasn't sure what it was exactly.The complaint device was received at the r&d and evaluated.During the analysis of the device, it was deemed that the motor presented a failure; however, as the motor cannot be disassembled to perform a repair, the devices must be discarded.The front seal of the motor is allowing saline to enter the motor during use.This causes the handpiece to stop functioning.This fault affects the reliability of the handpiece but does not adversely impact patient safety.Manufacturing record evaluation (mre) is not needed since the device falls into capa that was opened due to the motor cannot be disassembled to perform a repair.The products (283712 & 283812) produced with the original design (rev a) are not serviceable.The root cause is attributed to manufacturing involving a design change.There is a capa associated with this product code, most of the complaints received to-date are related to failed motors with evidence of water intrusion and manifested as malfunctioning or seized motors, therefore; the devices are under service discontinuation.This product issue is already being addressed by depuy quality system.Further investigation and assessment are covered under the capa in our quality system.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: SHAVER HANDPIECE 2.0 WITH BUTTONS
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18275480
• MDR Text Key: 330817248
• Report Number: 1221934-2023-04424
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 283812
• Device Lot Number: M15AB1498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 02/27/2024; 03/07/2024
• Supplement Dates FDA Received: 02/29/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1