MAUDE Adverse Event Report: DEPUY MITEK LLC US CORDCUTTER *EA; SUTURE CUTTER

Model Number 214646

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep that during a rotator cuff repair, the trigger of the cordcutter was not engaging the cutting piece.Another device was used to complete the procedure.No 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: investigation summary: the complaint device was not returned after multiple attempts for device return, 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 supplied was incorrect which precludes conducting a dhr review or a lot specific search in the complaints handling system.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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: 10206877
• MDR Text Key: 196822514
• Report Number: 1221934-2020-01681
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 10886705004270
• UDI-Public: 10886705004270
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

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: 214646
• Device Catalogue Number: 214646
• Device Lot Number: 10B09
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/29/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 07/30/2020
• Patient Sequence Number: 1