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

Model Number	VPF-706-X
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during an open reduction and internal fixation for zygomatic fracture, the suture needle was used to close the abdomen, the suture needle was broken, which made it unusable and increased the risk of surgery.Immediately search for the broken needle and find the broken end stump.The two broken ends were anastomosed, the incision was cleaned, and after confirming that there was no foreign matter remaining, replace the suture needle to continue suturing.No patient injury.

• 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 ; DR 0101
• MDR Report Key: 11186780
• Report Number: 9612501-2021-00099
• Device Sequence Number: 3726640
• Product Code: GAW
• UDI-Device Identifier: 10884521039933
• UDI-Public: 10884521039933
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2021

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: 04/30/2024
• Device Model Number: VPF-706-X
• Device Catalogue Number: VPF-706-X
• Device Lot Number: D9E2604Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 01/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 70