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

Model Number 228302

Device Problem Use of Device Problem (1670)

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

Event Date 03/29/2021

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.Udi: (b)(4).Investigation summary : according to the information provided, it was reported that knot pusher out of order.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual observations revealed that the device had some marks of wear adhesive tape near the handle as usual on these types of reusable devices.The inner shaft was removed, it was slightly bent, however the edge of the cutter was found slightly dull.The hub that covers the inner shaft was also reviewed for any anomalies and the edge was found dull as well.When performing the functional test, a sample suture was used, it was placed on the cutting hole, and it was difficult to cut the suture; it could not be possible to action the trigger.A manufacturing record evaluation was performed for the finished device lot number:21a03, and no nonconformances were identified.According with the visual inspection and the functional test result, this complaint can be confirmed.The possible root cause for this type of failure can be attributed the repeated and heavily use of the device; also, the continuous sterilization process.As stated on ifu 108484: end of useful instrument life is generally determined by wear or damage from handling or surgical use.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.

Event Description

It was reported by the sales rep in (b)(6) that during a meniscal repair procedure on (b)(6) 2021, it was observed that the arthro pusher/cutter device was out of order.During in-house engineering evaluation, it was determined that the inner shaft was slightly bent, the edge of the cutter and the hub that covered the inner shaft were found dull and the trigger was not possible to work; and therefore, it was difficult to cut the suture.Another like device was used to complete the procedure with a delay of five minutes.There were no adverse patient consequences nor surgical delay 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: 12348889
• MDR Text Key: 267506781
• Report Number: 1221934-2021-02539
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705010172
• UDI-Public: 10886705010172
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 08/19/2021

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: 228302
• Device Catalogue Number: 228302
• Device Lot Number: 21A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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