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

Model Number	VLOCM0014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an orthopedic procedure, the thread of the suture broke while doing a running stitch.An additional new suture was used without issue to complete the case.The patient has no injury.
Additional Manufacturer Narrative
Investigation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted an expired sample.The event date indicates that the product was used after the expiration date.The product should have been discarded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7300581
• Report Number: 1219930-2018-01102
• Device Sequence Number: 19331321
• Product Code: GAM
• UDI-Device Identifier: 10884521131651
• UDI-Public: 10884521131651
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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: 01/31/2017
• Device Model Number: VLOCM0014
• Device Catalogue Number: VLOCM0014
• Device Lot Number: A4A0549VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1