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

Model Number	CL-905
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
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, the thread broke making the suture line incomplete.In order to resolve the issue, the surgeon re-sutured the suture line.There was no patient injury involved.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of six devices.The visual inspection of the opened sample noted one suture and one needle.The foils were inspected with light assisted microscopy with no abnormalities.It was observed that the opened suture was in multiple pieces and appeared to have split from decomposition.A tensile test was performed on the sealed samples and the results exceeded the specifications for this product.However, during the test, one of the needles detached from the suture with very little effort.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.However, an assembly error was identified during product analysis.It was found that at least one of the samples sent back had incomplete adhesive transfer, which may have led to the suture degradation.He reported condition was most likely cause by an error with the feeding and sealing station.As the original machine was deactivated, the engineering investigation could not recreate the exact conditions under which the affected lot was manufactured, but they were able to recreate the reported condition under very unlikely circumstances.Since the affected lot was manufactured, the machine responsible was deactivated, and new equipment was introduced with additional safety features/capabilities.Additionally, packaging integrity test monitoring was established at the beginning and end of each shift.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 6769916
• Report Number: 9612501-2017-05901
• Device Sequence Number: 13896126
• Product Code: GAM
• UDI-Device Identifier: 10884521042957
• UDI-Public: 10884521042957
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 08/28/2019
• Device Model Number: CL-905
• Device Catalogue Number: CL-905
• Device Lot Number: D4H0814X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 01/29/2018; 02/28/2018; 06/20/2018; 08/08/2018
• Initial Report FDA Received Date: 08/06/2017
• Supplement Report FDA Received Date: 02/06/2018; 03/16/2018; 07/20/2018; 10/04/2018
• 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