MAUDE Adverse Event Report: ARTHREX, INC. FLEXIBLE REAMER, 10MM LOW PROFILE; BIT, DRILL

Model Number	FLEXIBLE REAMER, 10MM LOW PROFILE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/07/2019
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 devices wee reported to have been discarded.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 during an acl reconstruction the tip of the ar-1400f-100 flexible reamer broke when the doctor started drilling.When the reamer was pulled out it was noticed the tip was missing.The doctor felt all was retrieved.The rep noted that the location the doctor was drilling was very hard bone.It was replaced with an ar-1410lpf low profile flexible reamer and the same event occurred.Once again the doctor retrieved the broken fragments.The reamer was replaced a third time with another ar-1410lpf and the tip of the third broke as well.Again the doctor removed the fragments.At this point the drilling was completed.Then the rest of the case was completed without further issues.A few weeks later during a follow up exam and x-ray it was discovered there is still a fragment left in the tissue.A second scope procedure was performed to remove the fragment.

• Brand Name: FLEXIBLE REAMER, 10MM LOW PROFILE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8587992
• Report Number: 1220246-2019-01080
• Device Sequence Number: 16560656
• Product Code: HTW
• UDI-Device Identifier: 00888867207523
• UDI-Public: 00888867207523
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 04/30/2021
• Device Model Number: FLEXIBLE REAMER, 10MM LOW PROFILE
• Device Catalogue Number: AR-1410LPF
• Device Lot Number: 10041788
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1