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

Model Number	CL-516
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, in an orthopedic hip hemiarthroplasty procedure, while employing a normal suturing technique for the first layer during closing, the needle of seven (7) sutures broke.The first suture fell into the cavity and was removed.Another device was used to complete the case. there was no patient injury.
Additional Manufacturer Narrative
Concomitant products: cl-516 - cl-516 polysorb* 1 und 90cm kv34 x36, lot# a4a2308y cl-516 - cl-516 polysorb* 1 und 90cm kv34 x36, lot# a4a2308y cl-516 - cl-516 polysorb* 1 und 90cm kv34 x36, lot# a4a2308y cl-516 - cl-516 polysorb* 1 und 90cm kv34 x36, lot# a4a2308y cl-516 - cl-516 polysorb* 1 und 90cm kv34 x36, lot# a4a2308y cl-516 - cl-516 polysorb* 1 und 90cm kv34 x36, lot# a4a2308y 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, in an orthopedic hip hemiarthroplasty procedure, while employing a normal suturing technique for the first layer during closing, the needle of three (3) sutures broke.The first suture fell into the cavity and was removed.Another device was used to complete the case. there was no patient injury.
Additional Manufacturer Narrative
Additional information: g3 correction: b5, h6 additional review of the event and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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): 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: 19524802
• Report Number: 1219930-2024-02622
• Device Sequence Number: 8251965
• Product Code: GAM
• UDI-Device Identifier: 10884521040878
• UDI-Public: 10884521040878
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 08/21/2024

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: CL-516
• Device Catalogue Number: CL-516
• Device Lot Number: A4A2308Y
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 01/18/2024
• 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: Male