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

Catalog Number 214140

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

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).

Event Description

It was reported via phone by the sales rep that during a rotator cuff procedure, the needle was not smooth while trying to pass, as if something was bent.They swapped the device with another like device to complete the procedure.There were no patient consequences or delays.The device is being returned.

Manufacturer Narrative

(b)(4).

Event Description

It was reported via phone by the sales rep that during a rotator cuff procedure, the needle was not smooth while trying to pass, as if something was bent.They swapped the device with another like device to complete the procedure.There were no patient consequences or delays.The device is being returned.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and evaluated.Visually, there are no anomalies found on the device.All the parts seem intact and in good working condition.A needle was loaded into the device, it was passing smoothly.The needle was tested on a sample rubber strip.When the trigger was actuated, the needle deploys successfully.The complaint is not confirmed.We cannot determine a root cause for why the customer experienced the reported problem.Further observation revealed that the jaw to shaft pin indicated that the pin was protruding very slightly from right end of the shaft.Clamping excessive tissue between the jaws combined with repetitive twisting action exerts excess side load on the jaw-to-shaft pin, resulting in the jaw-to-shaft pin shearing off from its space.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 records reviewed.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 as a means of monitoring the extent with which this complaint is observed in the field.Udi:(b)(4).

Event Description

Additional information received on (b)(6)2018: there most likely was not an issue with the needle with this device, only the expressew applier itself.Another expressew applier with the same needle would have been how they completed the case.

• 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
• MDR Report Key: 7549389
• MDR Text Key: 109419093
• Report Number: 1221934-2018-50968
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705020218
• UDI-Public: 10886705020218
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

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 Catalogue Number: 214140
• Device Lot Number: 45699-180223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 12/20/2018
• Supplement Dates FDA Received: 06/25/2018; 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1