MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO GRASPER PEN 35 UP *EA; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 214601

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

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 during the a rotator cuff repair, surgeon was using a penetrating grasper 35° up, they heard a snap and the jaw would no longer close.The device was received and inspected.Visual inspection reveals that the device is worn due to it has marks of used.The shaft of the device was bent.The device was tested, as a result, the jaws do not open or close.Therefore, the mechanism to close and open the jaws was defective which contributing to a holding failure.This complaint can be confirmed.The cause of the failure is that it appears that the device has an extreme lateral force on the shaft which is the potential root cause of the failure.Also, could be related to fair wear and tear.A manufacturing record evaluation was performed for the finished device lot number: 10r02, 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.

Event Description

It was reported by sales rep in australia that during a rotator cuff repair, it was observed that the jaw on the penetrating grasper device no longer close.According to the reporter, the surgeon was using the device and heard a snap.During in-house engineering evaluation, it was determined that the shaft on the device was bent.Another device was used to pass sutures and complete the procedure.No surgical delay or patient consequences reported.No additional information was provided.

• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• 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: 10373338
• MDR Text Key: 201866027
• Report Number: 1221934-2020-02016
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705003846
• UDI-Public: 10886705003846
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214601
• Device Catalogue Number: 214601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1