MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	8886620731
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, pre-operatively, the thread had come off from the needle before suturing.A new device was used to resolve the issue.There was no patient involvement.
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.Five devices were returned for analysis.Of those devices, one of them was clinically used by the account and four were representative samples.Visual inspection noted the opened sample had one suture and one needle.The needle was returned disengaged from the suture.Upon microscopic inspection of the needle, normal crimp and swage marks were noted.Functional evaluation noted a needle attachment test was performed on the sealed samples, and the results met the specifications for this product.A review of the device history record indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.The reported condition was confirmed.The most likely cause could not be established from the information available.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 12137368
• Report Number: 9612501-2021-01121
• Device Sequence Number: 3704616
• Product Code: GAM
• UDI-Device Identifier: 10884523002270
• UDI-Public: 10884523002270
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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: 04/30/2025
• Device Model Number: 8886620731
• Device Catalogue Number: 8886620731
• Device Lot Number: D0E2309Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 06/15/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1