MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL BARREL TORNADO BURR 5.5MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 287889

Device Problem Mechanical Jam (2983)

Patient Problem Not Applicable (3189)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: according to the information provided, it was reported that the devices did not move/ turn.Surgery completed with new device.One complaint device was received and evaluated.It was visually inspected; the outer and inner of the device are stuck.Both pieces cannot be separated and not moving.Therefore, cannot be connected into the tornado shaver for test.This complaint can be confirmed.The external surface revealed marks of use, as the device is reusable.The assembly pieces was separated using excessive force to discern a root cause.It is possible that during use the ptfe sleeve of the inner tube can burst, which may be stuck inside, as well as rough use.There are inspections that check separately the outer and the inner part of the assembly.The potential cause cannot be associated to manufacturing.As per information added in pc notes, confirms that only received one device for evaluation.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number: m1902005, and no non-conformances were identified. at this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).

Event Description

Devices did not move/ turn.Surgery completed with new device.No harm to patient.Additional details provided by the affiliate reported there was a slight 2 minute surgical delay with no patient consequences.It was also reported that the device is available for return.

• Brand Name: BARREL TORNADO BURR 5.5MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10557270
• MDR Text Key: 208139025
• Report Number: 1221934-2020-02673
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 287889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1