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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
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DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Back to Search Results
Model Number SN-5663
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/12/2021
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, the needle detached from the thread, and the needle was temporarily lost during an open orthopedic procedure.The needle into the patient's cavity and was retrieved with a needle driver.Another device was used to complete the case.There was no patient injury.
 
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Brand Name
MONOSOF
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DR  0101
MDR Report Key11617370
Report Number9612501-2021-00544
Device Sequence Number3668119
Product Code GAR
UDI-Device Identifier10884521078253
UDI-Public10884521078253
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K900531
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/06/2021
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 Model NumberSN-5663
Device Catalogue NumberSN-5663
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/15/2021
Initial Report FDA Received Date04/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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