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

Model Number	223104
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on an unknown date, it was observed that the needle disassembled when the first stitch passed through the tissue.It was not reported if there was a delay in the surgical procedure.It was not reported if a spare device was available for use.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, the following additional information was received.It was reported that the event occurred during reconstruction of the anterior cruciate ligament.There was no delay in the surgery.The procedure was completed by using another suture of the same reference.There were no complications to the patient.D4 h4: the lot number, expiration date, and device manufacture date were all reported as unknown on the initial report.All fields have been updated accordingly.Therefore, udi: (b)(4).
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.H11 additional narrative: investigation summary: according to the information provided, it was reported that the needle is disassembled when the first stitch is passed through the tissue.The complaint device was received and evaluated.Visual observations confirm that the needle was detached and separated from the suture.The complaint can be confirmed.No other anomalies were observed.The possible root cause can be attributed to excessive tension applied in the suture or can be associated with the tissue can be thick and hard.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:6l00266, 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: d10, h3, 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.

• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10207292
• Report Number: 1221934-2020-01694
• Device Sequence Number: 2121311
• Product Code: GAT
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/12/2020

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 Expiration Date: 09/30/2022
• Device Model Number: 223104
• Device Catalogue Number: 223104
• Device Lot Number: 6L00266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 11/06/2020; 12/16/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/31/2020; 11/09/2020; 12/17/2020
• Patient Sequence Number: 1