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

Model Number	CL-977
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Impaired Healing (2378)
Date of Event	11/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during an open reduction of a right intertrochanteric fracture and proximal femoral locking plate internal fixation, the device was used to suture the muscles and subcutaneous tissues.However, five days later, the surgical wound healed poorly, with a little yellow clear exudate and obvious purulent secretions.The exudate was taken for bacterial culture on (b)(6), and the results were negative.Some synthetic absorbable surgical sutures were removed.The surgeon strengthened the dressing change of the surgical wound, cefazolin sodium, to prevent infection, and other symptomatic treatments were done to resolve the issue.
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 a hip right intertrochanteric fracture replacement and open reduction, proximal femoral locking plate internal fixation, the device was used to suture the muscles and subcutaneous tissues.However, five days later, the surgical wound healed poorly, with a little yellow clear exudate and obvious purulent secretions.The exudate was taken for bacterial culture on (b)(6) 2024, and the results were negative.Some synthetic absorbable surgical sutures were removed.The surgeon strengthened the dressing change of the surgical wound, cefazolin sodium was given to prevent infection, and other symptomatic treatments were done to resolve the issue.
Additional Manufacturer Narrative
Additional information: b1, b2 (removed), b5, g3, h6.New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction.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.

• Brand Name: POLYSORB
• 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: 21298462
• Report Number: 9612501-2025-00328
• Device Sequence Number: 13061286
• Product Code: GAM
• UDI-Device Identifier: 10884521044241
• UDI-Public: 10884521044241
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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: CL-977
• Device Catalogue Number: CL-977
• Device Lot Number: D4F3250FY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 02/14/2025
• Date Device Manufactured: 06/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female