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

Catalog Number	214157
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Udi: (b)(4).Investigation summary: the device was received for evaluation.Visual inspection under magnification reveals that there are several nicks and cuts on the top and bottom surfaces of the upper jaw.An expressew needle was placed in the device and fired.There was difficulty, the needle seemed to be binding and did not fire smoothly.The needle did not retrack.This complaint can be confirmed.As this is a reusable device, it is possible that tissue debris was lodged inside the shaft at the distal end and without proper cleaning/ sterilization; the device would become rough to operate over time.Another potential root cause could be the rough handling of the device that caused the nicks in the upper jaw.Other than these possibilities, we cannot discern a root cause for this failure.A manufacturing record evaluation was performed for the finished device lot number on 12-11-2019, and no non-conformances were identified.No further information regarding the cause of the defect has been provided to help determine the actual root cause for this failure.At this point in time, no corrective action is required, and no further action is warranted.However, 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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number on 12-11-2019, and no non-conformances were identified.Device history batch: null, device history review: null.
Event or Problem Description
It was reported by the affiliate in (b)(6) that the needle was consistently jamming in the expresssew iii ac gun device.According to the report, the needle jammed, removed and retested; however, it continued to jam.It was reported that the device jammed following surgery as the case still went ahead as usual without further delay.During in-house engineering evaluation, it was determined that there was difficulty firing the needle from the device as the needle seemed to be binding that it did not fire smoothly nor retract.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device was available for use.This event did not occur during surgery.There was no 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: 9481312
• Report Number: 1221934-2019-60006
• Device Sequence Number: 4202282
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 10/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1