MAUDE Adverse Event Report: ARTHREX, INC. 3MM SUTURE TAK SHAVERDRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	3MM SUTURE TAK SHAVERDRILL
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
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 during a procedure, the 3mm suturetak shaver drill, ar-1250ltsr, was being used with a disposable fish mouthed drill guide and metal shavings were noted in the joint after drilling.The surgeon was able to clear all shavings with a shaver.Additional information requested.Additional information provided 07/29/2020: type pf procedure being performed was a left shoulder stab.The rpm was set to 6200rpm in fwd.The hospital refused to allow dualwave into support the shaver system so fms duo was in use.There was no interruption in the flow of irrigation.Surgeon used bonecutter 4mm shaver to retrieve any metal savings he could see and the case concluded as normal.Additional information provided 08/4/2020: the reporter is not 100% sure that all fragments were retrieved; however, there were certainly none visible in the surgeons field of vision at the time the case ended.

• Brand Name: 3MM SUTURE TAK SHAVERDRILL
• 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: 10414335
• Report Number: 1220246-2020-02038
• Device Sequence Number: 2682800
• Product Code: HWE
• UDI-Device Identifier: 00888867239432
• UDI-Public: 00888867239432
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K932699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 3MM SUTURE TAK SHAVERDRILL
• Device Catalogue Number: AR-1250LTSR
• Device Lot Number: 10196756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other