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 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.(b)(4).

Event Description

It was reported by affiliate via personal interaction that during procedure, the cordcutter *ea became difficult to cut sutures.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.Additional information received by the affiliate reported the case was completed but could not provide further details.It was also reported the device is at the customer sit but will be returned for evaluation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.H10 additional narrative: investigation summar 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.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.A manufacturing record evaluation was performed for the finished device lot number (19k01), 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 a manufacturing record evaluation was performed for the finished device lot number (19k01), and no non-conformances were identified.

• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9899431
• MDR Text Key: 202753419
• Report Number: 1221934-2020-01013
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

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: No Information
• Device Model Number: 214646
• Device Catalogue Number: 214646
• Device Lot Number: 19K01
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 03/30/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/22/2020
• Patient Sequence Number: 1