MAUDE Adverse Event Report: COVIDIEN SOFSILK 4/0 18 BLACK CV-22; SUTURE, NONABSORBABLE, SILK

Model Number	GS44M
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of four sealed sofsilk 4/0 18 black cv-22 the visual inspection and functional evaluation of the sample had acceptable results.The returned sample, as received by medtronic, was found to meet medtronic quality specifications.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.Therefore, our investigation was unable to establish a relationship between the device and the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Event or Problem Description
According to the reporter.During a laminectomy, one of the needles broke.The broken piece was able to be retrieved.There was no patient injury.

• Brand Name: SOFSILK 4/0 18 BLACK CV-22
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): COVIDIEN; zona franca de san isidro; carretara san isidro km17; santo domingo ; DR
• MDR Report Key: 6360188
• Report Number: 9612501-2017-00305
• Device Sequence Number: 19027521
• Product Code: GAP
• UDI-Device Identifier: 10884521084902
• UDI-Public: (01)10884521084902(17)210531(10)D6E2689X
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/26/2016

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: 05/31/2021
• Device Model Number: GS44M
• Device Catalogue Number: GS44M
• Device Lot Number: D6E2689X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2016
• Initial Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR