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 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and inspected.When tested for its functionality, it was not able to cut the sutures.This complaint is confirmed.The reported failure can be attributed to normal wear and tear.The device is approximately 12 years old and it is expected to have wear and tear due to the nature of usage of the device.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A check of the manufacturing finished goods records for the reported batch number revealed no anomalies relating to the reported incident.There were no anomalies or discrepancies in the manufacture of this lot.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.Udi: (b)(4).

Event Description

It was reported by the sales rep that the customer's cord cutter was dull and not cutting during a rotator cuff repair.There were no patient consequences or delays.The case was completed with another like device.The sales rep was not present during the case and could not provide any more details.The device is being returned.

• Type of Device: SUTURE CUTTER
• 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: 9667700
• MDR Text Key: 200212466
• Report Number: 1221934-2020-00472
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 10886705004270
• UDI-Public: 10886705004270
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2020

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: 08D2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2008
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1