MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	N-2547
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	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: n-2547 monosof* 8-0 blk 13cm mv1355x12 (lot#: d3c0631y) n-2547 monosof* 8-0 blk 13cm mv1355x12 (lot#: d3c0631y) 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
It was reported that during a nerve injury right hand d2 and d3, while suturing after a patient incision, the needle detached from the suture.The needle did not fall into the patient cavity.Another two sutures were used but had the same issue. an additional new suture was used without issue. no patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that during a nerve injury right hand d2 and d3, while suturing after a patient incision, the needle detached from the suture.The needle did not fall into the patient cavity.Another six sutures were used but had the same issue.An additional new suture was used without issue.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant product: n-2547 monosof* 8-0 blk 13cm mv1355x12 (lot#: unknown) n-2547 monosof* 8-0 blk 13cm mv1355x12 (lot#: unknown) n-2547 monosof* 8-0 blk 13cm mv1355x12 (lot#: unknown) n-2547 monosof* 8-0 blk 13cm mv1355x12 (lot#: unknown) 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.Six sealed representative samples were returned for evaluation.The evaluation found no potentially contributing factors.It was reported that while suturing after a patient incision, the needle detached from the suture.The reported issue could not be confirmed.The most likely cause could not be identified because no r elated problem was detected with the device.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.

• Brand Name: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23352253
• Report Number: 9612501-2025-02755
• Device Sequence Number: 13016451
• Product Code: GAR
• UDI-Device Identifier: 10884521076082
• UDI-Public: (01)10884521076082(17)290531(10)D4F4348Y
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2025

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 Model Number: N-2547
• Device Catalogue Number: N-2547
• Device Lot Number: D4F4348Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/25/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 10/24/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE NOTE ON H11.; SEE NOTE ON H11.
• Patient Sex: Unknown