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

Model Number	SL-1689
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Post market vigilance (pmv) led a photographic evaluation of one device.Photographic inspection of the returned image noted an open foil pouch, multiple partial sutures and one needle detached.Further inspection of the foil pouch 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.
Event or Problem Description
According to the reporter, pre-operatively, upon opening the product the device thread broke.The surgeon the used another device to resolve the issue.There was no patient involvement.

• 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: 8872078
• Report Number: 9612501-2019-01524
• Device Sequence Number: 3039078
• Product Code: GAM
• UDI-Device Identifier: 10884521047556
• UDI-Public: 10884521047556
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 02/29/2020
• Device Model Number: SL-1689
• Device Catalogue Number: SL-1689
• Device Lot Number: D5B1247X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1