MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	CL-964
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Tissue Injury (4559)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); 88862818-89, 88862818-89 ticron* 5 blu 4x75cm kv40x12 (lot#unknown); 88862818-89, 88862818-89 ticron* 5 blu 4x75cm kv40x12 (lot#unknown) 88862818-89, 88862818-89 ticron* 5 blu 4x75cm kv40x12 (lot#unknown); 88863097-71, 88863097-71 ticron* 1 blu 75cm gs25x36 (lot#unknown); 88863097-71, 88863097-71 ticron* 1 blu 75cm gs25x36 (lot#unknown); 88863097-71, 88863097-71 ticron* 1 blu 75cm gs25x36 (lot#unknown); 88863097-71, 88863097-71 ticron* 1 blu 75cm gs25x36 (lot#unknown); 88863097-71, 88863097-71 ticron* 1 blu 75cm gs25x36 (lot#unknown); cl-964, cl-964 polysorb* 0 und 90cm gs24 x36 (lot#unknown); cl-964, cl-964 polysorb* 0 und 90cm gs24 x36 (lot#unknown); cl-964, cl-964 polysorb* 0 und 90cm gs24 x36 (lot#unknown); cl-964, cl-964 polysorb* 0 und 90cm gs24 x36 (lot#unknown); cl-964, cl-964 polysorb* 0 und 90cm gs24 x36 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown); sm-5638, sm-5638 biosyn* 3-0 und 75cm p12 x12 (lot#unknown).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, 81 days post-operative of an open total hip procedure where the sutures were used for skin closure using the interrupted ties suturing technique, the patient returned to the hospital due to wound dehiscence.The wound opened.A total of22 sutures were involved.Among the 22 sutures, the thread of 4 synthetic absorbable sutures broke.The patient will need to come back to the hospital for a reoperation for the wound excision/debridement.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19590352
• Report Number: 1219930-2024-02800
• Device Sequence Number: 14291338
• Product Code: GAM
• UDI-Device Identifier: 10884521043787
• UDI-Public: 10884521043787
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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-964
• Device Catalogue Number: CL-964
• 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: 05/23/2024
• Initial Report FDA Received Date: 06/21/2024
• 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: Hospitalization; Required Intervention; Other
• Patient Sex: Female