MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 214124

Device Problems Bent (1059); Partial Blockage (1065); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

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 evaluated.Visual observations revealed that the right side of the upper jaw hook was bent inwards.This type of failure could be attributed to blunt force impact; potential root causes include the device hitting bone during a procedure or the device being mishandled.When attempting to load a test needle in the needle tray, the needle could not fully be seated, there could be a blockage preventing the needle to fully enter the needle tray, confirming this complaint.Via functional test, when the trigger was actuated, the jaws did not function properly.The jaws did close or open successfully, however the jaw to shaft pin was intact.There two possible root causes for this type of functional failure: there is excess surgical debris jammed in the gun, or since the upper jaw was bent from blunt force impact there is a possibility that the internal mechanism of the jaw was damaged.Other than the possible root causes listed a specific root cause couldn¿t be determined at this time.The dhr review indicated that this batch of devices was processed without incident; therefore, there is no evidence of manufacturing anomalies on the records reviewed.Furthermore, a related complaint search in depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that was released to distribution.And at this 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.(b)(4).

Event Description

It was reported to the repair that there was difficulty with needle sliding through.Additional information received via email from the sales rep on 10-3-2017.Only information provided was: ¿difficulty with needle sliding through¿.There is no other information.There was no operating room incident report filed.

• Brand Name: EXPRESSEW III W/HOOK
• 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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 7659657
• MDR Text Key: 113337790
• Report Number: 1221934-2018-52892
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003655
• UDI-Public: 10886705003655
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 214124
• Device Lot Number: 32557-150602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1