MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD NOVAFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	8886445251
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
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, the needle detached from the suture.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of four device.The visual inspection of the open sample noted two partial sutures and one needle.The needle was observed to be detached from the sutures.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.The retainer was inspected with no abnormalities.The visual inspection and functional evaluation of the sealed samples had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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.
Event or Problem Description
According to the reporter, during gastric sleeve procedure, the needle broke away from the suture at the needle point attachment/ clamped join between the two.The separated parts were expelled from the patient and a new suture packet was opened to complete the procedure.There was no patient injury.

• Brand Name: NOVAFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7454146
• Report Number: 9612501-2018-00826
• Device Sequence Number: 1264388
• Product Code: GAT
• UDI-Device Identifier: 10884521100091
• UDI-Public: 10884521100091
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

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: 08/31/2021
• Device Model Number: 8886445251
• Device Catalogue Number: 8886445251
• Device Lot Number: D6H0701X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR