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

Model Number	214627
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Udi: (b)(4).Investigation summary: the complaint device was received and inspected.Visually, the device appears worn indicating device was used, but as expected condition and the laser markings are slightly faded.Under magnification, the distal end of the cutter has nicks and marks.When the trigger was tested, it feels rough as though the internal components are worn.When suture was loaded to test its functionality, it does not cut the suture cleanly, confirming this complaint.The device is over four years old.This failure can be attributed to fair wear and tear.There are no indications from this complaint investigation that the issue/failure is manufacturing-related, therefore a manufacturing record evaluation is not required.At this point, as this failure was not confirmed, 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.This report is being filed 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 affiliate in united kingdom that during shoulder stabilization procedure, it was observed thatthe arthro suture cutter sliding kit was blunt.According to the report, the device was not used previously and was on its first use.There was a delay in the surgical procedure of 45 minutes to an hour while the patient was under anesthesia.There was a another arthroscopic scissor from competitor device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional 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.Result codes and conclusion codes: upon further investigation, it was determined that the investigation results were operational and mechanical problems, and the conclusion cause was not established.Both fields have been updated accordingly to reflect the correct information.Investigation summary the complaint device was received and inspected.Visually, the device appears worn indicating device was used, but as expected condition and the laser markings are slightly faded.Under magnification, the distal end of the cutter has nicks and marks.When the trigger was tested, it feels rough as though the internal components are worn.When suture was loaded to test its functionality, it does not cut the suture cleanly, confirming this complaint.The device is over four years old.This failure can be attributed to fair wear and tear.There are no indications from this complaint investigation that the issue/failure is manufacturing-related, therefore a manufacturing record evaluation is not required.At this point, as this failure was not confirmed, 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.

• Common Device Name: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9129019
• Report Number: 1221934-2019-58643
• Device Sequence Number: 14066328
• Product Code: FZT
• UDI-Device Identifier: 10886705004096
• UDI-Public: 10886705004096
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Model Number: 214627
• Device Catalogue Number: 214627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/16/2020
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1