MAUDE Adverse Event Report: ARTHREX, INC. HOLDING SLEEVE, 2.0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	HOLDING SLEEVE, 2.0MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
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 sales representative via sems that an ar-18700-49, the plastic lobster claws snapped, and the ar-18700-25 screw from the holding sleeve rusted through.This was discovered during use in a procedure.No patient affect reported.There was no additional information provided.Requested additional information 12/15/2021.On (b)(6) 2021, it was reported by a sales representative via email the plastic lobster claw wasn¿t clamping and was falling apart during use.The screw retention sleeve fall into two pieces.The case was on (b)(6) with dr.(b)(6) finger fracture.The case was completed using just an external fixation.

• Brand Name: HOLDING SLEEVE, 2.0MM
• 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: 13154799
• Report Number: 1220246-2022-04248
• Device Sequence Number: 5299869
• Product Code: LXH
• UDI-Device Identifier: 00888867312746
• UDI-Public: 00888867312746
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/04/2022

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: HOLDING SLEEVE, 2.0MM
• Device Catalogue Number: AR-18700-25
• Device Lot Number: 1391947
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/04/2022
• Date Device Manufactured: 11/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown