MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON 2-0 CLEAR 30" C-14; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	8886661851
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	02/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter; during a laparoscopic procedure, the needle of the suture broke off and an x-ray was utilized to search for the fragment which had fallen into the femoral artery in proximity of the vascular system and resulting in an extension of the procedure by an hour.The fragment was removed from the patient and no damage was caused by the fragment.
Event or Problem Description
According to the reporter; during a laparoscopic procedure, the needle of the suture broke off and an x-ray was utilized to search for the fragment which had fallen into the in the moles near the femoral artery in proximity of the vascular system and resulting in an extension of the procedure by an hour.The fragment was removed from the patient and no damage was caused by the fragment.There was no injury to the patient and no blood loss.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned samples noted two empty foil pouches with a retainer, one suture and one broken piece of needle.The retainers were inspected with no abnormalities.The needle was broken at the swaged end.The broken swaged end of the needle was attached to a suture.It was observed, under magnification, that instrument marks were present on the broken swaged end of the needle.As no sealed products were returned, functional testing was precluded.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A review of the device history record indicates the product was released meeting all medtronic 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, can cause the needle to disengage from the suture, and can cause the needle to break at the swaged end.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.

• Brand Name: MAXON 2-0 CLEAR 30" C-14
• 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: 6415506
• Report Number: 9612501-2017-05154
• Device Sequence Number: 48291
• Product Code: GAM
• UDI-Device Identifier: 10884523001822
• UDI-Public: 10884523001822
• 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,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2018

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: 06/30/2021
• Device Model Number: 8886661851
• Device Catalogue Number: 8886661851
• Device Lot Number: D6F2790X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 05/02/2017; 01/19/2018
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 07/03/2017; 02/14/2018
• 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: Other
• Patient Age: 33 YR
• Patient Weight: 70