MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGILON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	8886195332J
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Radiation Exposure, Unintended (3164)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
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 craniotomy, needle breakage occurred when the doctor gripped the needle tip.X-ray was also performed, and nothing remained in the patient cavity.The part fell into the patient's cavity and could not be retrieved.Less than 200 cc of bleeding occurred and surgical time was extended by less than 30 minutes as a result of the issue.The procedure was completed with another device.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the opened samples noted one broken needle tip.Upon microscopic inspection, instrument marks were observed near the break site.As no sealed samples were returned, a bend moment test 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; therefore, a review of the device history record was not performed.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 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: SURGILON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8556116
• Report Number: 9612501-2019-00878
• Device Sequence Number: 2510888
• Product Code: GAR
• UDI-Device Identifier: 10884521072725
• UDI-Public: 10884521072725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981582
• 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): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8886195332J
• Device Catalogue Number: 8886195332J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention