MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN

Model Number	SP-690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an abdominal skin closure, the needle broke while suturing, resulting in fifteen minutes extended surgical time.A new suture was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d4 (unique identifier (udi) #), g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that one needle was received bent 4/5 of it's length away from the tip.The needle was returned intact.Upon microscopic inspection of the needle, normal crimp and swage marks were noted.Instrument marks were noted at the bent site.Visual inspection of the breathable pouch and foil pouch indicated no breaches or visual abnormalities.The suture was observed to be properly wound within the retainer.A tactile and microscopic inspection of the sutures was performed with no observed abnormalities.Microscopic inspection of the needles noted no damage or visual abnormalities.Functional testing found that the opened complaint device was precluded as the needle was returned already damaged and bent.No difficulty was experienced removing the sutures from the retainer.The wire diameter of the needles was verified to be 0.032 inches.The measurement was taken with a digital caliper, calibrated asset nh18593.A bend moment test was performed on the sealed samples and test results met the minimum bend moment specification for this product, 1160 grams of force per centimeter.Based on the results of the bend moment test, the representative samples tested satisfactory.It was reported that the needle broke.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: needle bent.The most likely cause could not be established from the information available.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: SURGIPRO
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN
• 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: 22007100
• Report Number: 9612501-2025-01274
• Device Sequence Number: 5228431
• Product Code: GAW
• UDI-Device Identifier: 10884521037533
• UDI-Public: (01)10884521037533(17)291130(10)D4M2253FY
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954808
• 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
• Report Date (Section B): 07/21/2025

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: SP-690
• Device Catalogue Number: SP-690
• Device Lot Number: D4M2253FY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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
• Patient Sex: Unknown