MAUDE Adverse Event Report: DEPUY MITEK LLC US ARTHRO KNOT MANIP FULL *EA; ARTHROSCOPIC SUTURING DEVICE

Model Number	214615
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep that during a rotator cuff repair surgery on 11/30/2021, it was observed that the arthro knot manip full device broke the suture after the knot was already tightened.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
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: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent 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.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual inspection under magnification revealed that the device had metal wear and there were scratches on the surface of the distal end.The laser markings were faded and not legible.The functional test was performed; as a result, the loaded suture was damaged.The reported failure can be confirmed.Manufacturing record evaluation was not required as the reported event was not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.The damage in the distal end would cause the device to cut the suture.The rough distal edges on the device are consistent with it coming in contact with other sharp metal instruments probably during sterilization or storage.This failure could be attributed to procedural variables, such handling of the device or product interaction during procedure.From its visual appearance, it was evident that the device has seen heavy use.As per ifu: inspect for damage prior to use and replace a damaged, worn or bent instrument.End of useful instrument life was generally determined by wear or damage from handling or surgical use.Also, it was necessary to follow the instructions and warnings of any cleaning and disinfection agents and equipment used; also, the recommendation of the proper condition during the sterilization and maintenance to avoid any damage, the device require special attention during cleaning.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Common Device Name: ARTHROSCOPIC SUTURING DEVICE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12964152
• Report Number: 1221934-2021-03652
• Device Sequence Number: 19280896
• Product Code: HCF
• UDI-Device Identifier: 10886705003983
• UDI-Public: 10886705003983
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2021

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: 214615
• Device Catalogue Number: 214615
• Device Lot Number: 17F01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 12/27/2021; 01/26/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown