MAUDE Adverse Event Report: DEPUY MITEK LLC US IDEAL SUTURE SHUTTLE 45 DEGREES LEFT; SUTURE/NEEDLE PASSER, SINGLE-USE

Model Number 251003

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi: (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.

Event Description

It was reported by the affiliate that during an articular labia reconstruction surgery that the wire from the ideal suture shuttle would not deploy from the needle tip.The surgery was completed using a second device with no patient harm.It was reported that the device was brand new and this issue happened on its first use.After the surgery, the wire was checked again and still could not be deployed.After washing the reported device the affiliate stated that it could be deployed smoothly a couple of times.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.A manufacturing record evaluation was performed for the finished device lot number:17r05, and no non-conformances were identified.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.

• Brand Name: IDEAL SUTURE SHUTTLE 45 DEGREES LEFT
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9124284
• MDR Text Key: 205880889
• Report Number: 1221934-2019-58576
• Device Sequence Number: 1
• Product Code: HCF
• UDI-Device Identifier: 10886705011643
• UDI-Public: 10886705011643
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2022
• Device Model Number: 251003
• Device Catalogue Number: 251003
• Device Lot Number: 17R05
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2020
• Patient Sequence Number: 1