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

Model Number 228302

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Not Applicable (3189)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.Upon visual evaluation, it was found that the cable had separated from handle.This complaint is confirmed.The hexagon socket set screw had come loose causing the cable to separate from the handle.It was noted that the device is missing the compression spring.The device appears worn indicating device was used, but as expected condition and the laser etchings are slightly faded.A manufacturing record evaluation was performed for the finished device lot number 18a08, 25 units were supplied on (b)(6), 2018 with no discrepancies.This device is approximately 2 years old and the reported failure can be attributed to normal field wear.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.(b)(4).

Event Description

It was reported by the sales rep via phone that during a meniscal repair procedure the handle on the customer's arthroscopic pusher/cutter separated from the shaft.The sales rep stated that there was no debris.The procedure was completed with another like device with no patient harm but there was a minute surgical delay to grab another device.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.

• 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: 9656088
• MDR Text Key: 202750760
• Report Number: 1221934-2020-00417
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2020

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: 228302
• Device Catalogue Number: 228302
• Device Lot Number: 18A03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1