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

Model Number	SMM-5044
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)
Date of Event	11/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure the needle of the device broke.The needle fell into the cavity of the patient and an x-ray was performed to locate the component.The needle was retrieved from the cavity and another device was used to complete the procedure.There was no injury to the patient.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.A tactile and microscopic inspection of the suture was performed with no abnormalities.The foil was inspected with light assisted microscopy with no abnormalities.The visual inspection of the sample noted one suture and one needle.The needle was received broken at the swaged end.Upon microscopic inspection of the needle, instrument marks were noted near the swaged end.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all manufacturer¿s quality release specifications at the time of manufacture.Holding the needle at the swaged end can cause the needle to bend or break.As per the ifu, the needle should be held in the middle, where the diameter is thickest.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, as per the additional information received, an x-ray was performed to locate the component or to confirm its' location and removed the needle from the cavity.It was an absorbable suture opened just prior to use that was not hydrated prior to use.No patient injury reported.Surgical time was extended by 30 minutes in order to perform the x-ray and locate the needle.

• Brand Name: MAXON
• 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: 7099050
• Report Number: 9612501-2017-06736
• Device Sequence Number: 901122
• Product Code: GAM
• UDI-Device Identifier: 20884523004646
• UDI-Public: 20884523004646
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2018

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: 03/31/2022
• Device Model Number: SMM-5044
• Device Catalogue Number: SMM-5044
• Device Lot Number: D7C2594X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 12/06/2017; 01/17/2018
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 12/20/2017; 02/13/2018
• 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: Required Intervention