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

Model Number	CLT-21-MG
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/24/2017
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 suturing of fascia, the tip of the needle broke and 2mm of it might have fallen into the patient's cavity.The procedure was completed with another device.Current patient status: unknown as extended process needed still.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.The visual inspection of the sample noted no sutures and 2 needles.The tip of one needle was observed to be broken off.Upon microscopic inspection of the broken needle, instrument marks were observed on the tip.As no sealed samples were received, functional testing was precluded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Grasping the needle at the swaged end or needle tip during application can damage the needle as observed.It is recommended that the needle be grasped from the needle body, where the wire is of a full diameter and significantly stronger than at the swaged end.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: 6887845
• Report Number: 9612501-2017-06238
• Device Sequence Number: 10964913
• Product Code: GAM
• UDI-Device Identifier: 20884521044545
• UDI-Public: 20884521044545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K900122
• 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
• Report Date (Section B): 02/16/2018

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: 03/31/2022
• Device Model Number: CLT-21-MG
• Device Catalogue Number: CLT-21-MG
• Device Lot Number: D7C1403X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 08/25/2017
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1