MAUDE Adverse Event Report: MICROLINE SURGICAL INC. RENEW RATCHETED HANDPIECE, 34CM, REUSABLE; MANUAL DETACHABLE SURGICAL INSTRUMENTS

Model Number	3914
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned to the manufacturer.Therefore, no investigation can be performed at this time.A follow-up report will be submitted if the device is returned.
Event or Problem Description
A small piece of black insulation missing when instrument was pulled out of the patient during surgery.The piece was unable to be located.Anesthesia time was extended by 30 minutes.

• Brand Name: RENEW RATCHETED HANDPIECE, 34CM, REUSABLE
• Common Device Name: MANUAL DETACHABLE SURGICAL INSTRUMENTS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 12738908
• Report Number: 1223422-2021-00010
• Device Sequence Number: 4127046
• Product Code: GEI
• UDI-Device Identifier: 00811099010579
• UDI-Public: 00811099010579
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K962119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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 Number: 3914
• Device Catalogue Number: 3914
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1