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

Model Number	SMM-5431
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.
Event or Problem Description
According to the reporter: occurred during hand tendon surgery.The needle and thread broke at the time of the insertion of the needle into the tendon.Another suture was used to resolved the issue.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of the device.The visual inspection of the returned product noted that one needle and one suture were received.The suture received was found to be broken.Instrumentation marks were noted on the suture adjacent to the break site.Analysis concluded there were no assembly component related failures; additionally, a review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.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: 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: 6736079
• Report Number: 9612501-2017-05842
• Device Sequence Number: 1607052
• Product Code: GAM
• UDI-Device Identifier: 20884523004691
• UDI-Public: 20884523004691
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 10/31/2021
• Device Model Number: SMM-5431
• Device Catalogue Number: SMM-5431
• Device Lot Number: D6K1265X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1