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

Catalog Number 214124

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the complaint device was received and evaluated.Visual observation revealed the upper jaw on the expressew iii was significantly deformed and bent outward.This contributed to the misalignment of the jaws and the failure of the passer to perform as intended.The reported complaint was confirmed.Historically, there are two known root causes for the bent jaw.One possible root cause is that the end user might have hit hard bone in the joint space forcing the jaws of the device and suture track to bend.Another possible root cause is that this instrument was not properly handled during cleaning and sterilization resulting in impact damage to the distal tip of the device.Based upon the investigation, the damage to the device (distal tip) was likely caused by improper handling, indicating user misuse.A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed one similar and one dissimilar complaint for this lot of devices that were released to distribution.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.(b)(4).

Event Description

It was reported by the sales rep that the distal tip of the customer's expressew iii with hook was bent prior to a rotator cuff repair.There were no patient consequences or delays.The case was completed with another like device.The device is being returned.

• Brand Name: EXPRESSEW III SUTURE PASSER 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 ; 5088808100
• MDR Report Key: 7475470
• MDR Text Key: 107345752
• Report Number: 1221934-2018-50550
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705003655
• UDI-Public: 10886705003655
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/03/2018

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 Catalogue Number: 214124
• Device Lot Number: 4430-110105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 05/01/2018
• Date Device Manufactured: 01/10/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1