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

Model Number	UM-877
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2017
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 the procedure, the needle came off the thread.The event occurred during the procedure but the product was not used for patient.The status of the patient is no problem.The procedure was completed with another device.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Summary of evaluation: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted a detached needle and a coiled suture in a retainer.Samples were forwarded to engineering for further evaluation of noted detached needle and a coiled suture in a retainer.Engineering concluded that the reported condition could be generated if a poor suture insertion into the needle is performed.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.The root cause of the observed condition of a detached needle was related to poor suture insertion by operator into the needle during the attaching process.The product analysis established a relationship between a device failure and the reported incident of a detached needle.The root cause of the observed condition was determined to be a result of a manufacturing error and corrective/preventive action has been implemented to prevent this condition from recurring.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIOSYN
• 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: 6861979
• Report Number: 9612501-2017-06142
• Device Sequence Number: 13755417
• Product Code: GAM
• UDI-Device Identifier: 20884521033457
• UDI-Public: 20884521033457
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2018

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: 11/30/2021
• Device Model Number: UM-877
• Device Catalogue Number: UM-877
• Device Lot Number: D6L2528X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 01/23/2018; 02/13/2018
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 02/08/2018; 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1