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

Catalog Number 214141

Device Problems Bent (1059); Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device was used for treatment, not diagnosis.(b)(4).The expiration date is currently unavailable.

Event Description

It was reported by the sales rep that the tip of their expressew needle broke during a rotator cuff repair.The needle tip could n ot be located in the patient.The case was completed with another like device.There were no patient consequences or delays.The device is being returned.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the complaint device has been received and evaluated.Visual observation confirms that the tip of the needle is broken, confirming this complaint.Additionally, the needle was discovered bent proximal to the plastic flag indicating the needle was loaded in the expressew gun with some resistance.For the broken distal tip of the needle per ifu, repeatedly passing the needle through excess tissue causes the needle to fatigue and break.Eiii needles have been designed to pass 15 times successfully through tissue and any usage beyond this would cause the needle to fatigue and eventually break.No further procedure information was provided to determine if the above reason contributed to this failure.Forceful attempts to load the needle in the needle tray could¿ve contributed to the breakage of the distal tip, however a specific root cause for the user to experience the reported failure could not be determined.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review into the depuy mitek complaints system revealed no complaints of any type 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.Udi: (b)(4).

• Brand Name: EXPRESSEW III NEEDLE PK5
• Type of Device: NEEDLE FOR USE WITH SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CLASSIC WIRE CUT COMPANY, INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7151772
• MDR Text Key: 95950918
• Report Number: 1221934-2017-50137
• Device Sequence Number: 1
• Product Code: LXH
• 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,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 214141
• Device Lot Number: 43072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other