MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MAXON CV; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	8886612411
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	05/04/2021
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, when performing mass resection of right thigh, forehead and left shoulder, the surgeon sutured the soft tissue after removing the forehead.When the first stitch was sutured, the needle tip broke in the soft tissue and broken needle was searched in the tissue immediately.It took about 10 minutes to find the broken needle.The operation continued.There was no patient injury.

• Brand Name: MAXON CV
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DR 0101
• MDR Report Key: 11966618
• Report Number: 9612501-2021-00950
• Device Sequence Number: 3604775
• Product Code: GAM
• UDI-Device Identifier: 10884523001761
• UDI-Public: 10884523001761
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K990951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: 01/31/2025
• Device Model Number: 8886612411
• Device Catalogue Number: 8886612411
• Device Lot Number: D0B2431Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 70