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

Model Number	SM-5627
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mastology procedure involving sm-5627 biosyn sutures, the thread broke in the middle; this occurred on three devices.Additionally, the needle separated from the thread three times while suturing or preparing the suture after the patient incision.These issues were associated with the same batch of sutures.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 products: sm-5627, sm-5627 biosyn* 4-0 und 45cm p12 x12 (lot#d4c3800fy); sm-5627, sm-5627 biosyn* 4-0 und 45cm p12 x12 (lot#d4c3800fy); sm-5627, sm-5627 biosyn* 4-0 und 45cm p12 x12 (lot#d4c3800fy); sm-5627, sm-5627 biosyn* 4-0 und 45cm p12 x12 (lot#d4c3800fy); sm-5627, sm-5627 biosyn* 4-0 und 45cm p12 x12 (lot#d4c3800fy).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: 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: 20929156
• Report Number: 9612501-2024-03089
• Device Sequence Number: 8391272
• Product Code: GAM
• UDI-Device Identifier: 10884521033054
• UDI-Public: 10884521033054
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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 Model Number: SM-5627
• Device Catalogue Number: SM-5627
• Device Lot Number: D4C3800FY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/13/2024
• Date Device Manufactured: 03/20/2024
• 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