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

Model Number	SP-665
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during the bunionectomy procedure, the needle popped off the thread.A new suture was used to resolve the issue.No patient adverse events reported.Patient is stable.

• 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: 6901474
• Report Number: 9612501-2017-06286
• Device Sequence Number: 13791619
• Product Code: GAW
• UDI-Device Identifier: 10884521037410
• UDI-Public: 10884521037410
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K010909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2017

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: 10/31/2017
• Device Model Number: SP-665
• Device Catalogue Number: SP-665
• Device Lot Number: D2K0555X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR