MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ORTHOCORD SUTURE VIOLET/BLUE, W/MO-6 NEEDLES, 12PK; POLYDIOXANONE SUTURE

Catalog Number	223115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2013
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.The product is not available for evaluation.Multiple attempts to retrieve the device have unsuccessful, the complaint device has not been returned.Should at some point the complaint device is returned, the file will be re-opened so the evaluation and root cause can be added.A batch record review has been conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.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.No preventative or corrective action is required.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.
Event or Problem Description
The sales representative reported broken orthocord sutures during an anterior cruciate ligament (acl) procedure.He stated the it was five (5) sutures total that broke.All of the sutures broke after the anchor was inserted and the surgeon was pulling sutures to test strength.These sutures came in packs of two (2) so they went through three (3) packs of sutures.The surgeon ended up using fiberwire to complete the procedure with no patient consequences.There was a thirty (30) minute delay.The sales representative stated it was a (b)(6) male with good bone quality.This was not a revision surgery.No further information could be provided.These sutures come in a box of twelve (12), the customer is returning the remaining packs of sutures of this lot they have for evaluation and as a courtesy we replaced the whole box for the customer.Please see also medwatch reports 1221934-2018-51217 and 1221934-2018-51220.

• Brand Name: ORTHOCORD SUTURE VIOLET/BLUE, W/MO-6 NEEDLES, 12PK
• 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: 7673714
• Report Number: 1221934-2018-51219
• Device Sequence Number: 19174964
• Product Code: NEW
• UDI-Device Identifier: 10886705008858
• UDI-Public: 10886705008858
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K040004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2013

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 Expiration Date: 04/30/2016
• Device Catalogue Number: 223115
• Device Lot Number: GE2569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2013
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR