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

Model Number	8886612411
Medical Device Problem Codes	Break (1069); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2019
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, pre operatively, the suture was not completely covered in the outer packaging, and part of the suture was outside the packaging.It was also reported that the suture thread broke and the surgeon believed that the problem was packaging.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Photographic and visual inspection noted that an opened foil pouch was returned.No breaches were noted in the packaging, except for the opening site.The visual inspection of the returned sealed products noted one suture and one needle.Microscopic inspection of the suture noted signs of breakage.The needle was broken around the middle, with both halves returned.Upon microscopic inspection, instrument marks were observed near the break site.As no sealed samples were returned, a bend moment test could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Additionally, the investigation detected a unreported condition of needle broken that has no relationship to the reported condition.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.The needle should always be held in the middle where the diameter is greatest.Grasping the needle near the swaged end or the tip could cause bends or breaks, or damage the connection between the needle and suture.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAXON CV
• 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: 9463760
• Report Number: 9612501-2019-02415
• Device Sequence Number: 3104199
• Product Code: GAM
• UDI-Device Identifier: 10884523001761
• UDI-Public: 10884523001761
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 07/31/2023
• Device Model Number: 8886612411
• Device Catalogue Number: 8886612411
• Device Lot Number: D8G0876X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1