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 Patient Involvement (2645)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received and visually inspected.Visual observations revealed no anomalies on the device.When the trigger was actuated, the jaws open and close as intended.A sample rubber strip was placed between the jaws and when the trigger was actuated, the jaws bite on the test strip without any gaps.Functionally, a test needle was attempted with the device but could not connect; there seemed to already be a piece of the reported needled jammed into the device, confirming the complaint.Since this is a reusable device, this failure has possibly occurred after using it in this manner for many procedures.A definitive root cause for this failure cannot be determined.A batch record 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 depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, 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.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 during a rotator cuff repair, it was observed that the customer's expressew iii needle became jammed inside their expressew autocapture gun when deployed.The sales rep confirmed nothing broke off while in the patient's joint space.The surgeon completed the procedure with another like device with no patient consequences or delays.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: 9071220
• Report Number: 1221934-2019-58356
• Device Sequence Number: 13485967
• Product Code: LXH
• UDI-Device Identifier: 10886705025190
• UDI-Public: 10886705025190
• Combination Product (Y/N): N
• 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): 01/21/2016

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: 02/11/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2016
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1