MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO PUSHER/CUTTER *EA; SUTURE CUTTER

Model Number 228302

Device Problem Degraded (1153)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a meniscal repair on 8/21/2020, it was observed that the blade of the arthroscopic pusher/cutter was dull and not cutting.Another device was used to complete the procedure.No adverse patient consequences or surgical delay 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: correction: d4: the lot number was reported as 1302 on the initial report.It was determined that this lot number was incorrect.Therefore, the lot number was unknown.Udi: (b)(4).Investigation summary :the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, the lot number reported was not correct which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.

• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10513635
• MDR Text Key: 207398468
• Report Number: 1221934-2020-02478
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: 10886705010172
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2020

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
• Device Operator: Health Professional
• Device Model Number: 228302
• Device Catalogue Number: 228302
• Device Lot Number: 1302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1