MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD PLAIN GUT; SUTURE, ABSORBABLE, NATURAL

Model Number	SG828
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	07/11/2019
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 a septoplasty when the surgeon was taking a pass through the nose with the needle, the surgeon pulled it out and the needle came off the strand.They opened another strand and after the first pass, the needle broke became stuck in the nose.They tried to locate the needle for an hour and eventually called on x-ray to help locate it, which worked and they located it and removed it.
Additional Manufacturer Narrative
Patient codes - (b)(6) (extended or time).Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the sample noted two suture fragment and four needles.Two of the needles were detached from the sutures.One of the needles was bend at the tip and swage.Upon microscopic inspection, instrument marks were noted near the swaged end of the needle.As no sealed samples were returned, needle attachment and bend moment testing could not be performed.A review of the device history record indicates this product was 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 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 could cause bends or breaks, or damage the connection between the needle and suture.Additionally, the reported condition of needle broken was not confirmed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PLAIN GUT
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8846778
• Report Number: 9612501-2019-01495
• Device Sequence Number: 11398193
• Product Code: GAL
• UDI-Device Identifier: 10884521056114
• UDI-Public: 10884521056114
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K885018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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: SG828
• Device Catalogue Number: SG828
• Device Lot Number: D8F0120ZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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