MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88862862-34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
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 while on curing the prominauris, the device thread broke.They then used another device to resolve the issue in order to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of nine devices.Visual inspection of the opened products noted seven needles and seven sutures, four of the sutures were partial.Each suture was attached to one needle.All needles had instrument marks on the tip and swages.Two of the needle tips were bent.A needle with a bent tip also had a bend near the swage.Instrument marks were noted near this bent site.A tactile and microscopic inspection of the sealed sutures was performed with no abnormalities.The foils were inspected with light assisted microscopy with no abnormalities.Bend moment testing was performed on the undamaged needles 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.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.The needle should always be held in the middle where the diameter is greate st.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7910195
• Report Number: 9612501-2018-01725
• Device Sequence Number: 1449152
• Product Code: GAT
• UDI-Device Identifier: 10884521058675
• UDI-Public: 10884521058675
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2019

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: 08/31/2022
• Device Model Number: 88862862-34
• Device Catalogue Number: 88862862-34
• Device Lot Number: D7H2682X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 02/20/2019; 03/26/2019
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 03/14/2019; 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1