MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III NEEDLE PK5; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number 214141

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported via phone by the sales rep that during a rotator cuff procedure, the tip of the customer's expressew iii needle broke.The sales rep stated the doctor dry fired the gun on the fifth pass because they were using permatape and wanted to be sure it was working properly, then on the sixth pass, the needle broke.The tip of the needle could not be found after looking on the floor, and on the permatape.The doctor did not want to do an xray.The device is being returned.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device was received and evaluated.The label was also returned, providing confirmation of product code, and lot number.Visual observation confirms that the tip of the needle is broken, confirming this complaint.The broken fragment was not returned for evaluation.Visually, the needle looked deformed from the proximal end near the flag, indicating the device was probably jammed in the needle tray and the user was attempting to free the needle loose.The user stated the device broke after the 6th fire.The device is designed to pass 15 times before a break can occur from fatigue.This breakage could then be only due to the interaction with the expressew gun that was used.The condition of the expressew gun is unknown.No information was provided.There could¿ve been a jam when the needle/gun was used together, which could¿ve damaged the distal tip and bent the needle.Other than the possible root causes listed a specific root cause could not be determined.A batch record review has been conducted and the results indicate that this batch of devices were processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed one dissimilar complaint for this lot of devices that were released to distribution.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.Udi: (b)(4).

• Brand Name: EXPRESSEW III NEEDLE PK5
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7614144
• MDR Text Key: 111487093
• Report Number: 1221934-2018-52042
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020225
• UDI-Public: 10886705020225
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 214141
• Device Lot Number: 46044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other