MAUDE Adverse Event Report: DEPUY MITEK EXPRESSEW III NEEDLE; MITEK ARTHROSCOPIC INSTRUMENT

Catalog Number 214141

Device Problem Break (1069)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 06/06/2017

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.The complaint device is not being returned and therefore not available for a physical evaluation.However, from past investigations of similar failure modes, it has been determined that repeatedly passing the needle through excess tissue causes the needle to fatigue and break.The needle could also break if it accidentally hits the bone or other instruments.Eiii needles have been designed to pass 15 times through tissue and any usage beyond this would cause the needle to fatigue.No further procedure information was provided to determine if the above reason contributed to this failure.A dhr review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.The complaint rate has been reviewed against the risk analysis document and found to be within the expected levels.Based on the complaint history, no further corrective action is warranted at this time.However, this file will remain receptive to any potential forthcoming information that is pertinent to this issue.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

The sales rep reported via phone that the tip of the customer's expressew iii needle broke off in the patient during a rotator cuff procedure.They located the debris with a ct scan and removed from patient.The case was completed with another like device.There were no adverse patient consequences with a thirty-minute time delay.The sales rep stated the device was discarded by the customer.

• Brand Name: EXPRESSEW III NEEDLE
• Type of Device: MITEK ARTHROSCOPIC INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6684284
• MDR Text Key: 78985477
• Report Number: 1221934-2017-10333
• 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: Other
• Type of Report: Initial
• Report Date: 06/06/2017

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: 02/01/2019
• Device Catalogue Number: 214141
• Device Lot Number: 41386
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2017
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other