MAUDE Adverse Event Report: COVIDIEN MAXON CL 4/0 18 P-13; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number SMM5536

Device Problems Out-Of-Box Failure (2311); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the suture detached from the needle after removing it from the package.The doctor opened another package and finished the procedure.There was no patient involvement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one maxon cl 4/0 18 p-13.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, engineering review of the product, and an evaluation of the returned sample.The initial visual inspection of the sample noted one suture and one needle.A tactile and microscopic examination of the sutures revealed no signs of material or assembly process damage.The foil was inspected with light assisted microscopy with no abnormalities.The needle was observed to be detached from the suture.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: MAXON CL 4/0 18 P-13
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer (Section G): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5933264
• MDR Text Key: 54092467
• Report Number: 9612501-2016-00564
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K990951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: SMM5536
• Device Catalogue Number: SMM5536
• Device Lot Number: D6C0882X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1