MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL ORTHOCORDVIOLET W/MO-6 NDLS PK/12; POLYDIOXANONE SUTURE

Catalog Number	223102
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint product was received and tested with an npd engineer.The returned samples of violet orthocord sutures were tested for straight break tensile strength.In each case, the results exceeded the acceptable standards.Design specifications for straight break test says that tensile strength must be a minimum of 46.8 lbs and the average results of this test for 3 samples were, passing the test.We cannot discern a root cause for this failure mode.Based on the complaint rate and customer impact, we believe this to be an anomaly.A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.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.(b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
This is report 1 of 3 for the same event.It was reported by the affiliate in (b)(6) that the orthocord violet w/mo-6 ndls pk/12 thread device was ripped over and over again during acl surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: ORTHOCORDVIOLET W/MO-6 NDLS PK/12
• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 7876092
• Report Number: 1221934-2018-54645
• Device Sequence Number: 2076325
• Product Code: NEW
• UDI-Device Identifier: 10886705008735
• UDI-Public: 10886705008735
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial
• Report Date (Section B): 05/30/2016

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: 10/31/2020
• Device Catalogue Number: 223102
• Device Lot Number: JM2862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2016
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUTURE DEVICES