MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SL-5687G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.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: occurred during knot tying during a skin lesion excision.4 absorbable sutures of the same lot number broke.These sutures had been opened or removed from the packaging for less than 5 minutes.Another suture was opened and used, without incident to resolve the issue.There was a patient involved in this event but there was no injury reported.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one hundred-sixteen devices.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: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6744098
• Report Number: 9612501-2017-05860
• Device Sequence Number: 670055
• Product Code: GAM
• UDI-Device Identifier: 20884521048741
• UDI-Public: 20884521048741
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 03/31/2022
• Device Model Number: SL-5687G
• Device Catalogue Number: SL-5687G
• Device Lot Number: D7C1465X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 06/29/2017
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1