MAUDE Adverse Event Report: STRYKER SPINE-US LUXOR ARM POST; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48250240
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 'tightening bar completely fell out of the hinge joint' on a luxor arm post intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay using an alternative device.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device, and laser markings and threads were found be worn.The device's slide rod, the mechanism that locks the arm, was disengaged from the main body.The device's retaining ring was also found to be loose, and its threads were worn.A functional inspection could not be performed, as the slide rod was unable to be placed back into its intended position.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The luxor surgical technique was reviewed and the following information was found: "the mediflex flex arm post mounts to the hospital bed rail.Check compatibility of the mediflex flex arm post to the hospital bed prior to surgery.Mount the arm post to the bed rail on the opposite side of the surgeon near the patient¿s hip.Turn the arm post locking mechanism clockwise to secure it to the bed.Once the arm post is secure, attach the snake arm to the arm post and lock into place." as the instrument was about 10 years old at the time of failure, routine wear/tear may have contributed to the loosening of the retaining ring, resulting in the disengagement of the slide rod.
Event or Problem Description
It was reported that the 'tightening bar completely fell out of the hinge joint' on a luxor arm post intra-operatively.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay using an alternative device.

• Brand Name: LUXOR ARM POST
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10316986
• Report Number: 0009617544-2020-00127
• Device Sequence Number: 14011947
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: 07613327266177
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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: 48250240
• Device Catalogue Number: 48250240
• Device Lot Number: 100131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1