MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNICUT 4.2 RES BLADE 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number	283345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Udi: (b)(4).The lot number is unknown at this time.
Event or Problem Description
It was reported by sales rep via complaint submission tool that during a shoulder repair, metallic deposit was released by the omnicut 4.2 (used w/ micro handpiece) just after activating the blade (before any contact with the tissue or the bone).Fragments were generated and procedure was completed by cleaning the joint and removing the metal on it with a surgical delay of 5 minutes.Additional information provided by the affiliate reported all fragments were removed from the patient but an x-ray was not done to confirm.
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 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.Investigation summary according to the information provided, it was reported by sales rep via complaint submission tool that during a shoulder repair, metallic deposit was released by the omnicut 4.2 (used w/ micro handpiece) just after activating the blade (before any contact with the tissue or the bone).The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, fragments metallic were observed.The complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The possible root cause for the reported failure can be attributed to excessive friction between the inner and outer blade.However, this cannot be conclusive determined.  given that lot number was not provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.  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.

• Brand Name: OMNICUT 4.2 RES BLADE 5PK
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10317812
• Report Number: 1221934-2020-01890
• Device Sequence Number: 11529413
• Product Code: HRX
• UDI-Device Identifier: 10886705022472
• UDI-Public: 10886705022472
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K041824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2020

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 Model Number: 283345
• Device Catalogue Number: 283345
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/02/2020
• Patient Sequence Number: 1