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

Model Number	GS-67-M
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	04/04/2019
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, on a laparoscopic segmentectomy, while suturing, two different needles broke into two parts.It was stated that one was found and the other one was not.The patient went through x-ray however, the missing piece was not found.The surgical time was extended for 30 minutes or more as the surgeon was trying to locate the missing broken part of the needle.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of twenty devices.A tactile and microscopic inspection of the sealed products was performed with no abnormalities.The visual inspection of the opened samples noted ten needles.Three needle was received broken at the tip and four needles were received bent at the tip as well.Upon microscopic inspection, instrument marks were observed near the break site of two broken needle.Functionally, a bend moment test was performed on the sealed sample 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.A definitive root cause could not be determined with regard to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 8540843
• Report Number: 9612501-2019-00847
• Device Sequence Number: 13553070
• Product Code: GAP
• UDI-Device Identifier: 20884521085128
• UDI-Public: 20884521085128
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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 Expiration Date: 06/30/2023
• Device Model Number: GS-67-M
• Device Catalogue Number: GS-67-M
• Device Lot Number: D8F0464X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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: Required Intervention