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 Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information provided, it was reported that during shoulder arthroscopy the device is no longer functioning.The device was received and evaluated.The visual inspection revealed that the device is discolored/fading off, small scratches and nicks were discovered.The device appears to be heavily used as indicated by the discoloring of the metal surfaces and dents on the chuck.This device could¿ve seen heavy use/high sterilization processes over time.A test suture was loaded on the inner shaft blade and the device did not successfully cut the suture.The release trigger was not worked as intended.Therefore, this complaint can be confirmed.The possible root cause can be related to excessive pulling force was applied which could¿ve of expand the diameter of the inner shaft¿s tip and it is possible that over the course of reuse of the device that the cutting end has become dull.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.

Event Description

It was reported by the affiliate in (b)(4) that during a shoulder arthroscopy repair procedure on an unknown date, it was observed that the cordcutter device was no longer functioning.During in-house engineering evaluation, it was determined that the device did not successfully cut the suture during suture test.The procedure was competed using the same device without delay.There were no adverse patient consequences reported.No additional information was provided.

• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 10838443
• MDR Text Key: 217342495
• Report Number: 1221934-2020-03483
• Device Sequence Number: 1
• Product Code: FZT
• UDI-Device Identifier: 10886705004270
• UDI-Public: 10886705004270
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• 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: 20C03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1