MAUDE Adverse Event Report: ARTHREX, INC. DRILL SLEEVE, AVN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	DRILL SLEEVE, AVN
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that an ar-3515h drill sleeve had an issue, the tip of the sheath bent whenever it touched the bone.This was discovered during use with no impact to the patient.During returned device evaluation, a reportable malfunction was discovered.
Additional Manufacturer Narrative
During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed.One unpacked ar-3515h was received for investigation.Visual inspection identified that the distal end of the c8967-01 tube was both dented and broken.The width of the tube was assessed using digital micrometer id: 224 and was identified to meet design specifications.Due to extent of the damage present, the id and od of the breakage site could not be assessed.The cause remains undetermined.

• Brand Name: DRILL SLEEVE, AVN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15183150
• Report Number: 1220246-2022-05339
• Device Sequence Number: 5977220
• Product Code: LXH
• UDI-Device Identifier: 00888867253230
• UDI-Public: 00888867253230
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/08/2022

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: DRILL SLEEVE, AVN
• Device Catalogue Number: AR-3515H
• Device Lot Number: 051643
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown