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

Model Number	SPB-1233G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, when the user started suturing, the thread broke.The procedure was completed with another device.There was no patient injury or adverse event.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Under magnification, instrument marks were observed at the swaged end of the needle.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Grasping the needle at the swaged end during application can damage the needle as observed.It is recommended that the needle be grasped from the needle body, where the wire is of a full diameter and significantly stronger than at the swaged end.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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: 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: 6746798
• Report Number: 9612501-2017-05863
• Device Sequence Number: 19065424
• Product Code: GAT
• UDI-Device Identifier: 20884521100777
• UDI-Public: 20884521100777
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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: 03/31/2022
• Device Model Number: SPB-1233G
• Device Catalogue Number: SPB-1233G
• Device Lot Number: D7C2354X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 07/27/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1