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

Model Number	8886645661
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/06/2020
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, during a breast reconstruction procedure, two sutures from the same box disengaged from the needle at the swage.A new device was used to resolve the issue and complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.A representative sample was available for evaluation.Twenty five products in sealed packages were received.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the needle unexpectedly separated from the thread.The reported issue could not be confirmed.The most likely root cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a breast reconstruction procedure, two sutures from the same box disengaged from the needle at the swage while using interrupted suturing technique.A new device was used to resolve the issue and complete the case.Surgical time was extended by approximately 30 minutes.There was no patient injury.

• Brand Name: MAXON
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 10323713
• Report Number: 9612501-2020-01061
• Device Sequence Number: 3178805
• Product Code: GAM
• UDI-Device Identifier: 10884521101692
• UDI-Public: 10884521101692
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 08/31/2024
• Device Model Number: 8886645661
• Device Catalogue Number: 8886645661
• Device Lot Number: D9J3023Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1