MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORTHOCORD VIOLET/BLUE SUTURE, W/NEEDLES; POLYDIOXANONE SUTURE

Catalog Number	223114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.The complaint device was received and visual observation confirms the suture is broken.There was no further information provided regarding the technique or instruments used in the procedure.We cannot determine a root cause for this failure.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.A complaint history search for this product code resulted in only one complaint for the last 2 years.We believe this failure to be an anomaly and based on the overall complaint rate, at this point in time, no further action is warranted.However, depuy 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.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
Affiliate reported that suture broke, surgery was finished successfully with a same like product.

• Brand Name: ORTHOCORD VIOLET/BLUE SUTURE, W/NEEDLES
• Common Device Name: POLYDIOXANONE SUTURE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle 2400 ; SZ 2400
• MDR Report Key: 7667187
• Report Number: 1221934-2018-51375
• Device Sequence Number: 11351649
• Product Code: NEW
• UDI-Device Identifier: 10886705008841
• UDI-Public: 10886705008841
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K043298
• 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
• Report Date (Section B): 10/24/2013

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 Catalogue Number: 223114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2013
• Initial Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1