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

Model Number	VP-733-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
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 closure of the dura on an open posterior decompression and chiari surgery, when tying one knot and used a running stitch, the thread broke.It was stated that it happened in four devices during same case.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual and tactile inspection noted that there were no abnormalities that would have caused or contributed to the reported condition.A tensile test was performed on the sealed samples and the results met the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO II
• 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: 9774426
• Report Number: 9612501-2020-00371
• Device Sequence Number: 19456859
• Product Code: GAW
• UDI-Device Identifier: 10884521038783
• UDI-Public: 10884521038783
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 01/31/2023
• Device Model Number: VP-733-X
• Device Catalogue Number: VP-733-X
• Device Lot Number: D8A1540SX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1