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

Model Number	SP-675
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
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 a procedure, while on wound closure, the device's needle broke.A new device was used to complete the case.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received thirty devices, one opened by the account and twenty-nine sealed with the appropriate packaging.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The visual inspection of the opened sample noted one suture and one needle detached.The needle was returned disengaged from the suture.Microscopic inspection did not note any bent broken sites on the needle a needle attachment test was performed on the sealed samples, three of the sutures were disengaged upon opening the product.Microscopic inspection of the needles detached upon opening noted crimp marks on the needle and a small amount of suture transfer material in the border of the swage entrance.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.The root cause was found to be poor insertion by the operator.Improvements have been initiated to mitigate this condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO
• 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: 8966685
• Report Number: 9612501-2019-01674
• Device Sequence Number: 13975035
• Product Code: GAW
• UDI-Device Identifier: 10884521037441
• UDI-Public: 10884521037441
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K954808
• 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): 11/21/2019

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: 07/31/2022
• Device Model Number: SP-675
• Device Catalogue Number: SP-675
• Device Lot Number: D7G1897FPX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1