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

Model Number	SL-608
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2016
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 to the reporter, during amygdalectomy procedure, the device thread was broken, the procedure occurred for 15 minutes.They opened another suture to resolve the case.The patient status was unknown.
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 one device.The visual inspection of the sample noted 1 needle.The needle was received broken at the swaged end.Under magnification, instrument marks were observed at the swaged end of the needle.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 secondary damage was misuse of the product which would have caused or contributed to the reported incident.Replication of this secondary damage may occur by grasping the needle at the swaged end during application which 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.
Event or Problem Description
According to the reporter, during amygdalectomy procedure, the device thread was broken, the procedure occurred for 15 minutes.They opened another suture to resolve the case.No patient injury reported.

• 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: 7066929
• Report Number: 9612501-2017-06662
• Device Sequence Number: 18863556
• Product Code: GAM
• UDI-Device Identifier: 20884521048888
• UDI-Public: 20884521048888
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2018

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: 04/30/2022
• Device Model Number: SL-608
• Device Catalogue Number: SL-608
• Device Lot Number: D7D0686FX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Supplement Date Received by Manufacturer: 11/28/2017; 01/23/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/18/2017; 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1