MAUDE Adverse Event Report: ARTHREX, INC. BONE GRAFT PREPARATION STATION, BASE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BONE GRAFT PREPARATION STATION, BASE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
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
It was reported that during a reverse bone graft surgery a screw for adjusting the saw angle of the device was stuck in the thread.The screw couldn`t be loosened again with pliers.No part of the device broke off.The surgeon has finished the surgery successfully freehand.There was no harm or adverse event for patient, operator or third party reported.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed, the angle knob is stuck and was found to be damaged.The cause of the seizure is undetermined as the knob could not be loosened and examined.The cause of the damaged is undetermined, though a likely cause is user-applied mechanical forces and/or damage from tooling.

• Brand Name: BONE GRAFT PREPARATION STATION, BASE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12268542
• Report Number: 1220246-2021-03479
• Device Sequence Number: 3531669
• Product Code: LXH
• UDI-Device Identifier: 00888867324831
• UDI-Public: 00888867324831
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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 Model Number: BONE GRAFT PREPARATION STATION, BASE
• Device Catalogue Number: AR-9670-1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other