MAUDE Adverse Event Report: DEPUY MITEK LLC US EXPRESSEW III W/O HOOK; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number	214140
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device was received and evaluated.Visual inspection revealed the device was in used condition.No needle was visible at the proximal or distal end of the device; the broken needle was not returned.Functional testing of the device revealed that actuation of the jaw lever caused the jaw to open and close as intended.A needle and suture were loaded into the device and the device was tested on a rubber strip.The needle deployed with the suture as intended, and the needle retracted as intended.The test was repeated approximately 15 times with consistent results.The reported device failure cannot be confirmed.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no internally assignable cause for the reported issue.Review of the depuy synthes mitek complaints system revealed 2 dissimilar complaints for this lot of 10 devices released to distribution.At this 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 to monitor the extent to which this complaint is observed in the field.This report is being filed from the etq complaint management system 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 that the customer's expressew iii without hook misfired repeatedly during a rotator cuff repair surgical procedure.According to the reporter, something was broke in the device causing the needle to break.The sales rep stated that the device did not break in the patient.The case was completed with a competitor product.There were no patient consequences or delays.The device will be returned for evaluation.The sales rep was not present for the case and could not provide any more details.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: EXPRESSEW III W/O HOOK
• Common Device Name: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8267902
• Report Number: 1221934-2018-52973
• Device Sequence Number: 2082261
• Product Code: LXH
• UDI-Device Identifier: 10886982153821
• UDI-Public: 10886982153821
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2016

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: 214140
• Device Lot Number: 28205-140910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1