MAUDE Adverse Event Report: ARTHREX, INC. PATELLA RESECTION GUIDE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PATELLA RESECTION GUIDE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
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) 2022, it was reported by a arthrex employee via sems that a ar-612-19 patella resection guide screw fell out, and the instrument came apart.This occurred during an unknown case, all pieces were retrieved, with no patient harm.No additional information provided, additional information requested.
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection, it was noted that the screw holding the groove leaf spring was missing and the spring was disassembled from the device.The screw was not returned for investigation.The cause could not be determined.

• Brand Name: PATELLA RESECTION GUIDE
• 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: 15311435
• Report Number: 1220246-2022-05434
• Device Sequence Number: 20200515
• Product Code: LXH
• UDI-Device Identifier: 00888867246164
• UDI-Public: 00888867246164
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/03/2023

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: PATELLA RESECTION GUIDE
• Device Catalogue Number: AR-612-19
• Device Lot Number: 1001211646
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown