MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	GS-33-M
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was previously submitted on a summary report.Subsequently, medtronic has received additional information which is being submitted via this 3500a.Post market vigilance (pmv) led an evaluation of two devices.The returned needle was received with a broken tip.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Grasping the needle at the tip can cause damage.It¿s recommended that the needle is grasped in the middle where the diameter is thickest.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, there were 2 of out the 5 needles that broke at the tip.The tip of the needle disengaged into the patient and it was retrieved by the physician with graspers.To complete the procedure, a new device was used.There was no harm caused to the patient.The device is expected to be returned for evaluation.

• Brand Name: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7316213
• Report Number: 9612501-2018-00322
• Device Sequence Number: 110437
• Product Code: GAP
• UDI-Device Identifier: 10884521084858
• UDI-Public: 10884521084858
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2018

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: GS-33-M
• Device Catalogue Number: GS-33-M
• Device Lot Number: D6E1658X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR