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

Catalog Number 251723

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2013

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 the complaint device was received and evaluated.Visual inspection reveals no anomalies on the device.When the inner shaft was tested, it rotates freely as reported, confirming this complaint.It appears as though the weld between the outer and inner shafts broke leading to this failure.A batch record review has been conducted and the results indicate that this batch of product was processed with an sda for an unrelated issue with no link to this complaint and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no similar complaints for this lot of 80 devices that were released to distribution.A review in the complaints system in the last one year did not reveal any other similar failures.Based on the complaint history and lot review, this failure seems to be an anomaly.A likely cause may have been exerting excess force or accidentally hitting bone during procedure.Other than this possibility, a root cause cannot be determined.At this point, no further action is warranted.However, depuy 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).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the affiliate in (b)(6) that during a rotator cuff repair surgical procedure, it was observed that when the doctor was trying to use the product at the surgery, it was found that the tip of the shaft was rotating and it could not be used.It was noted at the first time of use.There were no adverse consequences to the patient.Another product was used to complete the case.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: SUTURE GRASPER, 60 DEGREE
• 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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7699695
• MDR Text Key: 114428774
• Report Number: 1221934-2018-51548
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705012312
• UDI-Public: 10886705012312
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2013

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 Expiration Date: 06/01/2018
• Device Catalogue Number: 251723
• Device Lot Number: 3702601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2013
• Initial Date Manufacturer Received: 11/22/2013
• Initial Date FDA Received: 07/18/2018
• Date Device Manufactured: 06/12/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1