MAUDE Adverse Event Report: COVIDIEN NORTHHAVEN-MFG MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	8886616523
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the needle detached from the thread.The procedure was completed with another device.The status of the patient is no problem.
Additional Manufacturer Narrative
Investigation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned products noted two sutures and one needle.One of the sutures was detached from the needle, needle was not returned.One of the sutures was attached to the needle.It appeared that the needle had disengaged from the suture under tension.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Unfortunately because no sealed samples were received, a needle attachment test could not be performed.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTHHAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7036248
• Report Number: 1219930-2017-08802
• Device Sequence Number: 11045990
• Product Code: GAM
• UDI-Device Identifier: 20884523002246
• UDI-Public: 20884523002246
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 02/28/2021
• Device Model Number: 8886616523
• Device Catalogue Number: 8886616523
• Device Lot Number: A6B0274X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1