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

Model Number	VLOCM0114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 skin closure on a total hip replacement, the suture thread broke after taking just two ¿bites".There was no excessive force on the suture and the suture broke very easily.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.The visual inspection of the sample noted one suture and one needle.It was observed, under magnification, that the suture appeared to have split under tension at the looped end.The loop was not returned.Unfortunately, as no sealed samples were returned, a tensile strength test could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during skin closure on a total hip replacement, the suture thread broke after taking just two ¿bites".Th ere was no excessive force on the suture and the suture broke very easily.They took a new suture thread to complete the case.There was no patient injury.
Additional Manufacturer Narrative
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 NORTH HAVEN-MFG; 195 mc dermott rd; north haven CT 06473
• MDR Report Key: 7465020
• Report Number: 1219930-2018-02303
• Device Sequence Number: 1716529
• Product Code: GAM
• UDI-Device Identifier: 20884521131757
• UDI-Public: 20884521131757
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 07/31/2020
• Device Model Number: VLOCM0114
• Device Catalogue Number: VLOCM0114
• Device Lot Number: A7G0424VFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/08/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 07/26/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1