MAUDE Adverse Event Report: ARTHREX, INC. DRL SLVE FOR RETRO DRL GD,STEPPED; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	DRL SLVE FOR RETRO DRL GD,STEPPED
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2021 it was reported by a sale representative via sems that an ar-1204fds drill sleeve, has fallen apart.This was discovered during a procedure, no patient affect reported.There was no additional information provided.Additional information 9/23/2021 on (b)(6) 2021 it was reported by a sale representative via email that an ar-1204fds drill sleeve, seal broke between the drill sleeve and the round shoulder of the sleeve.This was discovered during use in a meniscal root repair procedure, on (b)(6) 2021.The surgeon was able to complete the case by using the drill sleeve without the round shoulder that came apart from the instrument.

• Brand Name: DRL SLVE FOR RETRO DRL GD,STEPPED
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12569541
• Report Number: 1220246-2021-03725
• Device Sequence Number: 14349152
• Product Code: MDM
• UDI-Device Identifier: 00888867004610
• UDI-Public: 00888867004610
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: DRL SLVE FOR RETRO DRL GD,STEPPED
• Device Catalogue Number: AR-1204FDS
• Device Lot Number: 031801
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/04/2021
• Patient Sequence Number: 1