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

Model Number	48250240
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Mechanical Jam (2983)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-operative preparation a luxor arm post 'will not tighten down to hold the retractor arm'.There were no adverse consequences to the patient.An alternative instrument was used to complete the procedure successfully without surgical delay.
Event or Problem Description
It was reported that during pre-operative preparation a luxor arm post 'will not tighten down to hold the retractor arm'.There were no adverse consequences to the patient.An alternative instrument was used to complete the procedure successfully without surgical delay.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device, and laser markings and threads were found be worn.Upon functional analysis, it was found that extra force was needed to turn the table clamp knob.When the knob was rotated, the threads grinded and experienced galling.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As the device was manufactured on 29-jan-2015 and has been used consistently for at least two years, it is likely that normal wear and tear contributed to this failure.

• 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: 10316849
• Report Number: 0009617544-2020-00126
• Device Sequence Number: 14011946
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: 07613327266177
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/25/2020

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: 149962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1