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

Model Number	XX-5229J
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during suturing, the thread broke in piece.The procedure was completed with another device.The status of the patient is no problem.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the noted zero sutures and one needle.The retainer was inspected with no abnormalities.The needle was observed to be detached from the suture.It appeared that the needle had disengaged from the suture under tension.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.As no sealed products were returned, functional testing was precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturers¿ quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.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: 6937518
• Report Number: 9612501-2017-06379
• Device Sequence Number: 11090861
• Product Code: GAM
• UDI-Device Identifier: 10884521113756
• UDI-Public: 10884521113756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: 02/28/2021
• Device Model Number: XX-5229J
• Device Catalogue Number: XX-5229J
• Device Lot Number: D6B2266X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 09/19/2017
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1