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

Model Number	GM-875
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	12/10/2024
Type of Reportable Event	Serious Injury
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a laparoscopic bilateral inguinal hernia repair, after the instruments and items were counted correctly before closing the body cavity, the surgeon disinfected the umbilicus.The scrub nurse on the operating table handed the surgeon a pair of fine forceps and a 0/5gm875 absorbable suture needle, which was clamped with a 14cm thick needle holder.When the surgeon was suturing the first stitch, the needle broke from the back 1/3 just halfway through the stitch.So the doctor on the operating table, the assistant and the scrub nurse began to search from the needle insertion point.The circulating nurse pulled an x-ray machine to assist in the search.After five to ten minutes, it was finally found and removed in the umbilical muscle layer.Then it was compared with the new intact suture needle and no missing was found.Another film was taken to confirm that there was no residue in the child's body.So the following surgical procedures continued.

• Brand Name: BIOSYN
• 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: 21473169
• Report Number: 9612501-2025-00555
• Device Sequence Number: 21010935
• Product Code: GAM
• UDI-Device Identifier: 10884521032828
• UDI-Public: 10884521032828
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GM-875
• Device Catalogue Number: GM-875
• Device Lot Number: D3L2993Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 11/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 MO
• Patient Sex: Male