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

Model Number	SP-623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during sub cuticular closure in a bilateral total knee replacement, three times the doctor tried to tie a knot with the suture the thread broke or the knot untied.Medical intervention was required to prevent a permanent impairment of function.The doctor used another manufacturers suture to complete the case because the suture knots were unsecured.Current patient status is alive with injury not due to our products.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO
• 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: 6423780
• Report Number: 9612501-2017-05161
• Device Sequence Number: 16257150
• Product Code: GAW
• UDI-Device Identifier: 10884521037076
• UDI-Public: 10884521037076
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K954808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2017

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: SP-623
• Device Catalogue Number: SP-623
• Device Lot Number: D5G0371X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Weight: 60