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

Model Number	GLJ-51-M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2019
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 sub total gastrectomy procedure, the needle tip was broke and was attached to the gauze but no problem occurred.It was pointed out by the doctor that no extensive force was applied to broke the needle and the product was defective.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of six devices, four of which were sealed, representative samples.The visual inspection of the returned sealed products noted that each sealed sample contained 5 needles and five sutures.A tactile and microscopic inspection of these sutures was performed with no abnormalities.Additionally, two needles with no suture attached were returned.One needle was intact, while one needle was received with the tip broken off.Upon microscopic inspection, instrument marks were observed near the break site.A bend moment test was performed on the sealed samples ad the results were found to meet the specifications of the 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 root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.The needle should always be held in the middle where the diameter is greatest.Grasping the needle near the swaged end or the tip could cause bends or breaks, or damage the connection between the needle and suture.No further actions have been deemed necessary at this time.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: 9463775
• Report Number: 9612501-2019-02416
• Device Sequence Number: 14186484
• Product Code: GAM
• UDI-Device Identifier: 20884521045559
• UDI-Public: 20884521045559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 02/29/2024
• Device Model Number: GLJ-51-M
• Device Catalogue Number: GLJ-51-M
• Device Lot Number: D9C0644Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1