MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	GL-69-MG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during an open mastectomy procedure, the device¿s needle broke 7mm from the tip.The tech found the needle piece outside the patient.Nothing fell into the patient cavity.No adverse events were reported.The patient is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the image noted no sutures and 1 needle.The needle tip was broken off.The needle was disengaged from the suture.The second image showed paperwork related to the event.As no sealed samples were returned, bend moment testing could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.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.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6837207
• Report Number: 9612501-2017-06069
• Device Sequence Number: 13612460
• Product Code: GAM
• UDI-Device Identifier: 20884521045474
• UDI-Public: 20884521045474
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 02/06/2018

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: 02/28/2022
• Device Model Number: GL-69-MG
• Device Catalogue Number: GL-69-MG
• Device Lot Number: D7B1973X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 01/27/2018
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR