MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	VPF-807-X
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during a vascular anastomosis in the right groin procedure, the needle broke.The needle fell into the patient cavity and was retrieved ; an x-ray was performed (b)(6) 2017.The suture is not an absorbable suture.An extension in surgical time due to the product problem.Patient status: unknown.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: per additional information received, the suture was hydrated prior to use.A continues stitch was employed by the surgeon.The current patient status is healthy and cured.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one hundred devices sealed with the appropriate packaging in an undamaged condition.The sealed products were forwarded to engineering for bend moment testing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection and functional evaluation of the sample had acceptable results.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.Based on the evidence available the reported condition was not confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: during a vascular anastomosis in the right groin procedure, the needle broke.The needle fell into the patient cavity and was retrieved ; an x-ray was performed (b)(6) 2017.The suture is not an absorbable suture.An extension in surgical time due to the product problem.The suture was hydrated prior to use.A continues stitch was employed by the surgeon.The current patient status is healthy and cured.

• Brand Name: SURGIPRO LL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6503421
• Report Number: 9612501-2017-05366
• Device Sequence Number: 978997
• Product Code: GAW
• UDI-Device Identifier: 20884521040066
• UDI-Public: 20884521040066
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K010909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: VPF-807-X
• Device Catalogue Number: VPF-807-X
• Device Lot Number: D6F0242X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: Not provided; 04/24/2017; 10/24/2017; 11/21/2017
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 05/25/2017; 09/07/2017; 11/17/2017; 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 76 YR