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

Model Number	VP-705-X
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the needle broke.They told for 2 years we have been in dialogue with the supplier about problems with broken and bent needles and threads that also break.They have received 5 unintended events with needles that have broken during a surgery.The pouring date is just an example of date as there have been many events.They always try to find tips that are broken, but because of the very small metal pieces that are hardly visible, there may be instances where microscopic metal pieces are left in the patient.
Additional Manufacturer Narrative
Correction: supplemental report created to correct previously sent information.The event date is not available and was sent in error in the initial report.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: 8155285
• Report Number: 9612501-2018-02213
• Device Sequence Number: 251849
• Product Code: GAW
• UDI-Device Identifier: 20884521038230
• UDI-Public: 20884521038230
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K050947
• 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): 03/12/2019

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: 07/31/2020
• Device Model Number: VP-705-X
• Device Catalogue Number: VP-705-X
• Device Lot Number: D5G2184X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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