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

Model Number	SM-693
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
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 an open procedure, the device was broken.They removed affected sutures that were not used to resolve the issue and complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted 1 suture and 1 needle.It was observed, under magnification, that the suture appeared to have split under tension.Unfortunately, as no sealed products were received, a tensile strength test could not be performed.A review of the device history record (dhr) indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an ovario-hysterectomy procedure, the device was broken.They removed affected sutures that were not used to resolve the issue and complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIOSYN
• 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: 7365806
• Report Number: 9612501-2018-00585
• Device Sequence Number: 19346272
• Product Code: GAM
• UDI-Device Identifier: 20884521033280
• UDI-Public: 20884521033280
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 10/31/2021
• Device Model Number: SM-693
• Device Catalogue Number: SM-693
• Device Lot Number: D6K1207FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 08/08/2018
• Initial Report FDA Received Date: 03/23/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1