MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283429

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

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.Investigation summary
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> according to the information provided, it was reported that during an unknown procedure the ultra aggressive plus 4.0mm 5pk had metallic debris.The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Since the complaint device was not available, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.The possible root cause for the reported failure can be attributed to interaction between two devices that cannot rotate freely.However; this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device lot/serial number (b)(4), and no non-conformances were identified.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the affiliate via complaint submission tool that during an unknown procedure the ultra aggressive plus 4.0mm 5pk had metallic debris.No patient consequence was reported, however there was a 5 minutes surgical delay.No additional information was provided.Additional information provided by the affiliate reported 15 blades were involved in this complaint and the event occurred when the shaver was turned on at the beginning of a knee arthroscopic surgery.There were no known user or patient impacts due to the metallic shavings and the case was completed with a new blade.The reporter also stated the fragments were easily removed by washing the joint and additional surgical intervention is not required.

• Brand Name: ULTRA AGGRESSIVE PLUS 4.0MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9741873
• MDR Text Key: 194847466
• Report Number: 1221934-2020-00648
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283429
• Device Catalogue Number: 283429
• Device Lot Number: M1905040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1