MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	VLOCM3225
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.Only the packaging of the product was returned.Visual inspection of the returned packaging noted an open foil pouch and retainer.It was reported that the suture thread broke, the device had bent out of its intended shape, and the tip of the needle was blunt or dull.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, after the second pass when closing an open total knee revision, the needle bent and became dull then the suture broke.The malfunction happened twice.A new suture was used.There was no patient injury.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 11987658
• Report Number: 1219930-2021-02329
• Device Sequence Number: 3059759
• Product Code: GAM
• UDI-Device Identifier: 10884521162365
• UDI-Public: 10884521162365
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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 Expiration Date: 09/30/2023
• Device Model Number: VLOCM3225
• Device Catalogue Number: VLOCM3225
• Device Lot Number: A0K0402VY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR