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

Model Number	SJ493GX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Emotional Changes (1831); Pain (1994); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Date of Event	09/15/2025
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.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, during skin biopsy in a clinical study, the needle broke causing severe pain.The needle had to be excised from the biopsy site with a scalpel.It was mentioned that the administered anesthetic during the procedure was insufficient due to conflict with other medications.After the procedure, the patient continued to experience severe uncontrolled pain.The patient had loss of ability to work, impacted activities of daily living, and emotional changes.The patient requested a third-party imaging center for an x-ray to confirm that there was no metal left from the needle breakage.The patient is currently still experiencing physical pain and tenderness at the wound site and is on both topical and oral antibiotics.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but 82 photos were available for evaluation.Visual inspection noted that there was no needle was observed in any of the returned images.Of the eighty-two pictures provided, nine images were returned with the suture observable.A suture was observed to be knotted at a surgical site.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 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: MCKESSON
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23583533
• Report Number: 9612501-2025-03040
• Device Sequence Number: 21242929
• Product Code: GAM
• UDI-Device Identifier: 20612479214570
• UDI-Public: (01)20612479214570(17)300531(10)D5F3221FY
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: SJ493GX
• Device Catalogue Number: SJ493GX
• Device Lot Number: D5F3221FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2025
• 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: Disability; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic
• Patient Race: White