MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO SUTURE SCISSORS *EA; SUTURE CUTTER

Catalog Number	214605
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device was received and evaluated.Visual observation revealed that the distal tip was slightly bent and the device looked worn with scratches.A test suture was tested with the device and the device failed to cut the suture cleanly.Upon further investigation, the blade appeared dull.The root cause can be attributed to normal wear and tear of the device form normal use and sterilization.Further, a review into the mitek complaints system revealed no other complaints for this serial number that was released to distribution.At this point, no corrective action is required and no further action is warranted.A device history record 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.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the sales rep that during a shoulder/rotator cuff surgical procedure, it was observed that the top jaw of the customer's suture scissors would not work and when trying to fix it the top piece of the device broke off.The sales rep stated that the device did not break in the patient.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences but there was a minute delay.The sales rep was not present for the case therefore could not provide any further information.The sales rep stated that only the handle part will be returning for evaluation and that the top piece was discarded.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.

• Common Device Name: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8261309
• Report Number: 1221934-2018-52114
• Device Sequence Number: 11180627
• Product Code: FZT
• UDI-Device Identifier: 10886705003884
• UDI-Public: 10886705003884
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 214605
• Device Lot Number: 4J2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1