MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	FLIPCUTTER II, SHORT 10.5MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the drill guide hit the tip of the ar-1204as-105 flipcutter ii and the tip broke off.All broken pieces were retrieved by the surgeon.

• Brand Name: FLIPCUTTER II, SHORT 10.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11629849
• Report Number: 1220246-2021-02849
• Device Sequence Number: 11517080
• Product Code: HWE
• UDI-Device Identifier: 00888867004290
• UDI-Public: 00888867004290
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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: FLIPCUTTER II, SHORT 10.5MM
• Device Catalogue Number: AR-1204AS-105
• Device Lot Number: 928898029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/07/2021
• Patient Sequence Number: 1