MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO LL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	SP-5698
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, on (b)(6) 2017, pre-operatively, the device broke, there was a damage at the level of the eye of the needle.No patient involved.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned samples noted one partial suture and one needle.The retainer was inspected with no abnormalities.The needle was broken/damaged at the swage end and detached from suture.It was observed, under magnification, that instrument marks were present on the swaged end of the needle.As no sealed products were returned, functional testing was precluded.A review of the device history record indicates the product was released meeting all 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 and significantly stronger than at the swaged end.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: SURGIPRO LL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6816770
• Report Number: 9612501-2017-06008
• Device Sequence Number: 13483086
• Product Code: GAW
• UDI-Device Identifier: 20884521036991
• UDI-Public: 20884521036991
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 12/31/2021
• Device Model Number: SP-5698
• Device Catalogue Number: SP-5698
• Device Lot Number: D6M0187X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1