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

Model Number	VP-733-X
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/09/2019
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, intra-operatively, the needle was broken in package prior to it being taken out.No patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the opened samples noted two needles attached by one suture.One of the needles was bent near the tip.Upon microscopic inspection, normal crimp and swage marks were observed on the needle.As no sealed samples were returned, a bend moment 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.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the needle was broken in package prior to it being taken out, it was being held by a rubber shod and broke on its own even though it had not been touched.The device was not used on the patient.

• 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: 8312638
• Report Number: 9612501-2019-00198
• Device Sequence Number: 2229262
• Product Code: GAW
• UDI-Device Identifier: 10884521038783
• UDI-Public: 10884521038783
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2019

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: 09/30/2023
• Device Model Number: VP-733-X
• Device Catalogue Number: VP-733-X
• Device Lot Number: D8J1268SX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/14/2019; 04/09/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/06/2019; 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1