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

Model Number	L-2752K
Medical Device Problem Codes	Break (1069); Dull, Blunt (2407)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during a squint procedure the used device needle broke.When using the device to suture the conjunctiva and the surrounding muscles, the needle did not pass through the tissue easily and the surgeon had to use force to pass the point of the needle.This issue occurred with 5 sutures each from 2 different lots (total of 10 sutures).The surgical time was extended more than 30 minutes and there was tissue damage and loss as a result of this complaint.The extent of the tissue damage and loss will not be made available.No additional operation will be needed.The patient status is listed as alive with no injury.
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 four devices.The visual inspection and functional evaluation of the sample had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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: 6689218
• Report Number: 9612501-2017-05721
• Device Sequence Number: 57015
• Product Code: GAM
• UDI-Device Identifier: 10884521046559
• UDI-Public: 10884521046559
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 11/28/2017

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: 05/31/2020
• Device Model Number: L-2752K
• Device Catalogue Number: L-2752K
• Device Lot Number: D5E0214X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 10/30/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/30/2017; 11/28/2017
• 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