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

Model Number	48250240
Medical Device Problem Codes	Fracture (1260); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a luxor arm post 'would not clamp onto the bed railing tightly enough' outside the operating room.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
The reported issue was confirmed via visual inspection.The pin at the proximal end of the arm post (where the arm attached to a bed) sheared off causing loose connection.Wear and slight discoloration were noticed on the device.The device is no longer functional.Device and complaint history records were reviewed for this lot, no relevant manufauring issues or similar complaints were identified.Per the sales rep, the device was lubricated, it has been used successfully previously and it was in sales rep possession for a approximately one year.The instrument is distributed as loaners to multiple sales reps and the exact usage cannot be confirmed.Per manufacturing history review the product is in the field for over 1.5 years.Wear after repeated use and excessive force while attaching to bed may have contributed to pin shearing off.The most likely cause of the reported event is normal wear and tear.
Event or Problem Description
It was reported that a luxor arm post 'would not clamp onto the bed railing tightly enough' outside the or.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• 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: 11362630
• Report Number: 0009617544-2021-00020
• Device Sequence Number: 837835
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: 07613327266177
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 197202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1