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

Model Number	8886661841
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	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) 8886661841, maxon 3-0 clr 75cm c14x36 8886661841, (lot #d9k0334fy) evaluation summary: medtronic conducted an investigation based upon all information received.Seven representative and two opened devices were available for evaluation.Three images were also available.Photographic inspection noted the end of the sutures were sticking out from the retainers.Visual inspection of the returned samples observed the needles were disengaged from sutures.Further assessment noted the proper attachment marked in the needle barrel and suture tip.It was reported that the thread was detached from the eight needles.The reported issue was confirmed.The root cause of the observed condition was determined to be due to poor suture insertion into the needle during the attaching process.Internal process improvements have been initiated to mitigate this issue.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, pre-operatively, after opening the package, it turned out that the thread was detached from the eight needles.The next suture with another lot number was used to resolve the issue.There was no patient involvement.

• 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
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19548968
• Report Number: 9612501-2024-01449
• Device Sequence Number: 4811747
• Product Code: GAM
• UDI-Device Identifier: 10884523004014
• UDI-Public: 10884523004014
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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: 09/30/2024
• Device Model Number: 8886661841
• Device Catalogue Number: 8886661841
• Device Lot Number: D9K0334FY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown