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

Model Number 214140

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2020

Event Type  malfunction  

Manufacturer Narrative

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: according to the information provided, it was reported that during a shoulder scope procedure the needle of the expressew iii suture passer w/o hook was not retracting anymore.The complaint device was received and evaluated.Visual observations revealed that the expresssew is slightly worn and used, but in expected condition.The capture jaw is in good condition, it's not bent and could be opened and closed easily.When performing the functional test, the needle stood stuck when the trigger was released, it has to be pushed back manually to it¿s original position.Therefore this complaint can be confirmed.The possible root cause for the jamming condition can be related to the constant use of the device that wears away it's internal parts.Since this device is reusable, the metal begins to lose it's shape due to the continuous usage causing wear of internal components leading to rough deployment issues.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.

Event Description

It was reported by the sales rep that during a shoulder scope procedure, it was observed that the needle of the expressew iii suture passer w/o hook was not retracting anymore.Another device was used to complete the procedure.No patient consequences or surgical delay reported.During in-house engineering evaluation, it was determined that the needle stood stuck when the trigger was released while performing the functional test.No additional information was provided.

• Brand Name: EXPRESSEW III W/O HOOK
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 10331879
• MDR Text Key: 202235097
• Report Number: 1221934-2020-01928
• Device Sequence Number: 1
• Product Code: HWQ
• UDI-Device Identifier: 10886705020218
• UDI-Public: 10886705020218
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214140
• Device Catalogue Number: 214140
• Device Lot Number: 23477-140627-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1