MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSSEW III AC GUN; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214157
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the complaint device was received and inspected.Visually, it was observed that the ratchet latch assembly was not functional, and the jaws were not closing.Upon further investigation it was found that the linkage between the ratchet and the ratchet latch is not functioning as intended, preventing functionality of the jaw.This type of failure is a design feature to ensure that in the event the device is used beyond its intended use (for ex: clamping too much tissue, repetitive twisting etc), the linkage failure will occur within the handle and prevent loose bodies from leaving the device.This failure can be attributed to device use.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy mitek complaints system revealed one other 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.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure, but before being used on the patient, the sales rep's expressew iii autocapture flexible suture passer jaws would not close.The case was completed with another like-device with no patient harm or delays.The sales rep stated that after the procedure while inspecting the device, he might have broken the needle inside the device.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: EXPRESSSEW III AC GUN
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9110673
• Report Number: 1221934-2019-58472
• Device Sequence Number: 16911506
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 214157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1