MAUDE Adverse Event Report: DEPUY MITEK 60° SUTURE GRASPER; MITEK ARTHROSCOPIC INSTRUMENT

Catalog Number 251723

Device Problem Bent (1059)

Patient Problem Tissue Damage (2104)

Event Date 11/28/2015

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation and therefore a root cause for this failure cannot be discerned.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.From the complaint history, it seems that this failure is an anomaly and an isolated incident.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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).

Event Description

It was reported that during arcr the hook of the device did not retract after the fourth piercing through the damaged rotator cuff.It was brand new and the first use when the issue occurred.The device was discarded at the hospital.The surgeon suspected this incident occurred because the wire in the shaft might have bent.There was no surgical delay or harm to the patient.The backup device was used to complete the case.

• Brand Name: 60° SUTURE GRASPER
• Type of Device: MITEK ARTHROSCOPIC INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: joseph cipollo ; 325 paramount drive; raynham, MA 02767 ; 5089773839
• MDR Report Key: 5309215
• MDR Text Key: 33824979
• Report Number: 1221934-2015-10138
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• 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: 11/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 251723
• Device Lot Number: 3853402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2015
• Initial Date Manufacturer Received: 11/28/2015
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other