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

Model Number	UL-878
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Swelling/ Edema (4577)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the patient underwent right achilles tendon rupture repair surgery, after successful anesthesia, a 7 cm longitudinal incision was made on the inside of the achilles tendon rupture, and the skin, subcutaneous tissue, and deep fascia were cut layer by layer until the achilles tendon stump was exposed.The achilles tendon was torn in a horsetail shape about 4 cm above the calcaneal tuberosity, and the plantar tendon was normal.The blood clots were cleaned, the stump was combed, and two high-strength sutures (sutures used in conjunction with bone anchors) were overlapped to suture the achilles tendon stump, with interrupted suture, and several stitches were sutured through the middle of the tendon.A medium 3.5x13.2 non-absorbable anchor with thread was then inserted into the calcaneal insertion point, and the achilles tendon was strengthened and fixed by braiding suture proximally.Checking that the calcaneal tuberosity was equal to the opposite side, the tension of the achilles tendon was restored, the wound was rinsed, and each layer was tightly sutured with synthetic absorbable surgical suture 2-0, sterile dressing was applied with pressure bandage, tourniquet was loosened, and the lower limb was fixed with plaster posterior support at 30° knee flexion and slight talar flexion.Post operatively, on (b)(6) 2025, it was found that the postoperative incision was red, swollen, and cracked, deep into the achilles tendon, and the achilles tendon was necrotic.After that, the necrotic part was completely removed, the suture was removed, and another suture was used to repair the achilles tendon, and it was re-sutured.After active dressing changes, the patient gradually recovered.
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.

• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22717326
• Report Number: 9612501-2025-02112
• Device Sequence Number: 21133895
• Product Code: GAM
• UDI-Device Identifier: 10884521049635
• UDI-Public: (01)10884521049635(17)291130(10)D4M2308Y(20)01
• 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
• Report Date (Section B): 08/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: UL-878
• Device Catalogue Number: UL-878
• Device Lot Number: D4M2308Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/05/2025
• Date Device Manufactured: 12/17/2024
• 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: 23 YR
• Patient Sex: Male