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

Model Number 228302

Device Problems Mechanical Problem (1384); Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

It was reported by the sales rep that during a meniscal repair surgery on (b)(6) 2021, it was observed that the arthro pusher/ cutter device prematurely cut the suture before the surgeon anticipated cutting it.During in-house engineering evaluation, it was determined that the device was not able to cut; and that the cutter tip edge was found to be dull.Another device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Udi: (b)(4).Investigation summary : according to the information provided, it was reported that during a meniscal repair the arthroscopic pusher/ cutter prematurely cut the suture on the truespan before the surgeon anticipated cutting it.The complaint device was received and evaluated.No anomalies were observed on the exterior of the device.When performing the functional test, the device was not able to cut.The retaining bolt was removed to verify the cutter shaft, the cutter tip edge was found to be dull.A manufacturing record evaluation was performed for the finished device 17j01 number, and no non-conformance were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint cannot be confirmed.Upon testing the device, it was not able to cut the suture, which is the opposite of the issue reported.A possible root cause can be related to another sharp instrument that was in contact with the suture which may have cut the suture instead of the cutter.The root cause for the dull edge can be attributed to the repeated and constant use of the device, as a result of this, the device cannot perform smoothly.Per the ifu 107540, it is recommended to inspect all instruments before sterilization or storage to ensure the complete removal of soil from surfaces, tube, holes, and moveable parts and if soil is still present, reclean the instrument.Also, ifu 107540 recommends to visually inspect the instrument and check for damage and wear; verify that all cutting edges are free of nicks and have a continuous edge; verify that moveable parts have smooth movement without excessive play; inspect that locking mechanisms fasten securely and close easily; and verify that long, thin instruments are free of bending and distortion.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Type of Device: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12935160
• MDR Text Key: 284468738
• Report Number: 1221934-2021-03621
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: 10886705010172
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: 17J01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Date Manufacturer Received: 12/06/2021
• 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: Unknown
• Patient Sequence Number: 1