MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORTHOCORD VIOLET W/MO7 TAPRNDL * PK/12; POLYDIOXANONE SUTURE

Model Number	223104
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
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 customer in (b)(6) that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the orthocord violet w/mo7 taprndl suture device broke at the time of knotting.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.H6: 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.H10 additional narrative: investigation summary: according to the information provided, it was reported that during the rotator cuff repair procedure, two sutures were broken at the time of knotting, they were reviewed and the reason they broke was not the knotter.The complaint device is not being returned, therefore unavailable for a physical evaluation, however a two videos were provided.In the videos can be observed that the customer has a set of blue orthocord sutures, they are mentioning that the sutures are in a wet condition.They used a knot manipulator tool to pass the sutures through the hole and then applied tension and friction on the sutures and the result is a frayed suture, however, none of the sutures were broken.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the video review, this complaint can be confirmed.The possible root cause for the broken sutures can be attributed to an excessive force that was applied at the moment of tightening, also the act of fractioning the suture with an instrument can contribute to a suture damage.As per ifu 108147 in handling this or any other suture material, care should be taken to avoid damage when handling.Avoid the crushing or crimping damage due to the application of surgical instruments such as forceps or needle holders.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.
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 during the rotator cuff repair procedure, two sutures were broken at the time of knotting, they were reviewed and the reason they broke was not the knotter (attached video of evidence and photos of the product).The complaint device has been received and evaluated.Upon visual inspection, it was observed that the suture is broken in four pieces, the suture is frayed at the ends.A manufacturing record evaluation was performed for the finished device 7l96175 number, and no non-conformances were identified.As part of depuy synthese mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, this complaint can be confirmed.The customer provided two videos which shows that they used a knot manipulator tool to pass the sutures through the hole and then applied tension and friction on the sutures and the result is a frayed suture.The possible root cause for the broken sutures can be attributed to an excessive force that was applied at the moment of tightening, also the act of fractioning the suture with an instrument can contribute to a suture damage.As per (b)(4) in handling this or any other suture material, care should be taken to avoid damage when handling.Avoid the crushing or crimping damage due to the application of surgical instruments such as forceps or needle holders.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12721337
• Report Number: 1221934-2021-03209
• Device Sequence Number: 3750938
• Product Code: NEW
• UDI-Device Identifier: 10886705008759
• UDI-Public: 10886705008759
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/19/2021

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 Expiration Date: 02/29/2024
• Device Model Number: 223104
• Device Catalogue Number: 223104
• Device Lot Number: 7L96175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/28/2021; 12/02/2021; 12/14/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 11/29/2021; 12/03/2021; 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown