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

Model Number	214627
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).The lot number is unknown at this time.
Event or Problem Description
It was reported by the sales representative via email that some of the delivered arthro suture cutter sliding *ea instruments very difficult to open (even if they open correctly the lock system included in the instruments concerned).The sales representative was not present when this was discovered and could not confirm the condition of the instrument.Additional information received from the sales representative reported there are still some trays for these instruments to be delivered some components are in back order.The customer can still not send the instruments to be sterilised and they don¿t want to open the instruments received because they don¿t want to take the risk to damage it without trays.It was also reported the hospital is an establishment which has opened recently new theatre but they still don¿t operate or have any activities on theatre as they need to make sure to follow all the trainings required and provided by the medical industries to be qualified to use equipment and material.An establishment which has opened recently new theatre but they still don¿t operate or have any activities on theatre as they need to make sure to follow all the trainings required and provided by the medical industries to be qualified to use equipment and material as long they don¿t have all the trays delivered.It was later reported the sales representative tested instruments and did find that they were difficult to open.
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.H10 additional narrative: d4: the lot number was reported as unknown on the initial report and has been updated to 19c02; therefore, udi: (b)(4).Investigation summary: according to the information provided, it was reported that that the customer noticed me that she found some instruments very difficult to open.The complaint device is not being returned, therefore unavailable for a physical evaluation.However a video was provided.Upon visual inspection of the video, the device was observed that presented some difficulties to open easily.The complaint reported was confirmed.The possible root cause for the reported failure can be attributed to the heavy use and repeated cleaning/ sterilization cycles.The failure of this device can be attributed to fair wear and tear.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [19c02] number, and no non-conformances were identified.  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.
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.H10 additional narrative: correction: d10, h3, h6: it was inadvertently missed on the previous report that the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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.Investigation summary according to the information provided, it was reported that that the customer noticed me that she found some instruments very difficult to open.The complaint device was received and evaluated.Visual observations and visual inspections in the video provided confirm that device presented some difficulties to open easily.In addition, the device presented marks of wear in the trigger and in the tip of the shaft.The complaint reported was confirmed.The possible root cause for the reported failure can be attributed to the heavy use and repeated cleaning/ sterilization cycles.The failure of this device can be attributed to fair wear and tear.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [19c02] number, and no non-conformances were identified.  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.

• Common Device Name: SUTURE CUTTER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10323276
• Report Number: 1221934-2020-01914
• Device Sequence Number: 11491058
• Product Code: FZT
• UDI-Device Identifier: 10886705004096
• UDI-Public: 10886705004096
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 07/09/2020

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
• Device Lot Number: 19C02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 08/01/2020; 09/28/2020; 09/28/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/28/2020; 09/28/2020; 09/29/2020
• Patient Sequence Number: 1