MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRESSEW III AUTOCAPTURE + SUTURE PASSER; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 288233

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Investigation summary: the complaint device was received and evaluated.Visual observations revealed that the upper jaw of the complaint device has been significantly deformed.When the trigger was actuated, the jaws open and close without difficulty.A sample rubber strip was placed between the jaws and when the trigger was actuated, the jaws bite on the test strip.However, the jaws leave a significant gap and do not close as intended.The misalignment due to the upper jaw being bent is stopping the jaws from opening and closing as intended.This complaint can be confirmed.We cannot determine a definite root cause for the reported failure.However, this type of failure has been historically attributed to blunt force impact/ mishandling, a user issue.A review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed one 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.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.(b)(4).

Event Description

It was reported by the sales rep that the jaw on the customer's expressew iii auto capture+ gun would not close during a rotator cuff repair.The case was completed with another like device.There were no patient consequences or delays.The sales rep was not present during the case and could not provide anymore details.The device is being returned.

• Brand Name: EXPRESSEW III AUTOCAPTURE + SUTURE PASSER
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; CH CH-2400
• Manufacturer (Section G): CLASSIC WIRE CUT COMPANY, INC.; 28210 constellation road; valencia CA 91355
• Manufacturer Contact: jean boissonnat ; chemin blanc 38; le locle CH-24-00 ; CH CH-2400
• MDR Report Key: 7241875
• MDR Text Key: 99219608
• Report Number: 1221934-2018-50136
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: (01)10886705027101(10)40889-161215
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/30/2018

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
• Device Operator: Health Professional
• Device Model Number: 288233
• Device Catalogue Number: 288233
• Device Lot Number: 40889-161215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1