MAUDE Adverse Event Report: DEPUY MITEK LLC US 60° SUTURE GRASPER; SUTURE/NEEDLE PASSER, REUSABLE

Catalog Number 251723

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

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.(b)(4).Incomplete.The expiration date is not currently available.

Event Description

It was reported that when the surgeon tried to take the suture out of the patient¿s body, the wire came out together and could not be handled any further during arthroscopic rotator cuff repair surgery on (b)(6) 2018.Much tension was not put to the wire.The surgery was finished without any other problem though it was not reported how the surgery was completed.It was brand new and the first use when the issue occurred.There was no harm to the patient.The following information was obtained on 5-20-2018: no broken pieces fell inside the patient.No procedural or patient anatomical problems which may have contributed to the failure.There is no surgical intervention planned.There was no patient impact.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The expiration date is not currently available.

Manufacturer Narrative

Product complaint # pc-(b)(4).It was documented in the initial medwatch report that the expiration date was unknown.The expiration date (feb 28, 2023) has been updated.The unique identifier (udi) has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.Investigation summary: the complaint device was received and inspected.The complaint cannot be confirmed.All parts of the device were attached.The wire of the device was bent perpendicular to the elbow tube.When the surgeon was attempting to pull the suture out of the patient's body, the wire may have bent out of its intended shape due to the tension of the suture.Therefore, a potential root cause for the reported failure may be use misuse applying excessive tension to the suture.However, we cannot discern a definitive root cause for the reported failure.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate 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 no other complaints of any kind for this lot of devices with the product code that were released to distribution.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).

• Brand Name: 60° SUTURE GRASPER
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7537736
• MDR Text Key: 109053290
• Report Number: 1221934-2018-50774
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• 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,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 251723
• Device Lot Number: L758117
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/31/2018
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1