MAUDE Adverse Event Report: ETHICON INC. MONOCRYL (POLIGLECAPRONE 25) SUTURE; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number C389

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that a patient underwent a dental surgery procedure on an unknown date and suture was used.During the procedure the needle pulled off the suture.Another device was used to complete the procedure.4 days post procedure, it was reported that the sutures broke and the patient underwent another procedure.The patient is reported as fine.Additional information has been requested.

Manufacturer Narrative

It was reported that a patient underwent a dental surgery procedure on an unknown date and suture was used.Four days post procedure, it was reported that the suture broke and the patient underwent another procedure on that (b)(4) post operative day.The patient's current condition is good.Attempts have been made to retrieve the device.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.

Manufacturer Narrative

The event could not be replicated.This report is not intended to deny customer experienced a problem with the device.The cause of the described breakage post-op could not be determined based on received actual sample.No further investigation for breakage could be conducted at the actual sample after aprox.4 weeks exposition to air humidity.

• Brand Name: MONOCRYL (POLIGLECAPRONE 25) SUTURE
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-UK; simpson parkway, kirkton campu; s; livingston ; UK
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5788205
• MDR Text Key: 49362591
• Report Number: 2210968-2016-10349
• Device Sequence Number: 1
• Product Code: GAN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: C389
• Device Lot Number: HP5CZWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/14/2016; 08/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention