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

Model Number	8886624561
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According the reporter, during a procedure, the thread of the product broke and on another suture, the needle was detached.A new suture was opened to complete the case.There was no patient injury noted during this event.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of a device.The visual inspection of the sample noted two partial sutures and two needles in an unlabeled container.The needles were observed to be detached from the suture.Upon microscopic inspection of the needles, normal needle crimp and swage marks were observed on each needle.It was observed, under magnification, that instrument marks were present on the swaged end of each needle.The retainer and the foil pouch were inspected with no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The observed instrumentation damages suggested that the needles were grasped improperly at the swaged end of the needle during application.Firmly grasping the needle at the swaged end can deform the crimp and cause the needle to disengage from the suture.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.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.

• 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: 6987043
• Report Number: 9612501-2017-06508
• Device Sequence Number: 16446842
• Product Code: GAM
• UDI-Device Identifier: 10884523002492
• UDI-Public: 10884523002492
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: 07/01/2020
• Device Model Number: 8886624561
• Device Catalogue Number: 8886624561
• Device Lot Number: B5G0282X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1