MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORTHOCORDVIOLET W/OS-6 NDLS PK/12; POLYDIOXANONE SUTURE

Model Number	223103
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot number was unknown.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 affiliate in (b)(6) that during an unknown procedure, while using an orthocord violet suture with os-6 needles, single pk, the needle teared off from suture.Then they opened a new package from another lot and it also teared off.A new suture blister was opened to complete procedure with a surgical delay of three minutes.No patient consequence 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: 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.
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: complaint description it was reported by sales rep via complaint submission tool that during an unknown procedure, while using an orthocord violet suture with os-6 needles, single pk, the needle teared of from suture.Then they opened a new package from another lot and it also teared off.A new suture blister was opened to complete procedure with a surgical delay of 3 minutes.No patient consequence reported.Investigation summary: 12 unused/unopened sterilize packed needles were received in opened package/box.Upon visual inspection, there was no damage noticed to the devices nor to the sterilized packages.Thus, complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [6l73466] number, and no non-conformances were identified therefore there is no evidence of manufacturing anomalies on the records reviewed.We cannot discern any definite root cause for the reported condition.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.

• Brand Name: ORTHOCORDVIOLET W/OS-6 NDLS PK/12
• 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: 10212919
• Report Number: 1221934-2020-01718
• Device Sequence Number: 16712681
• Product Code: GAT
• UDI-Device Identifier: 10886705008742
• UDI-Public: 10886705008742
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K040004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2020

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: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: 223103
• Device Catalogue Number: 223103
• Device Lot Number: 6L73466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/10/2020; 07/28/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/13/2020; 07/29/2020
• Patient Sequence Number: 1