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

Model Number	48250240
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a luxor arm post securing mechanism disengaged intra-operatively.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Upon visual inspection, it can be seen that the device is worn.Laser markings of catalog/ lot number are worn and outer surface shows some discoloration.The device's clamp was able to attach onto a surface without issues.The device's slide rod, the mechanism that locks the arm, was not returned with the device.The threads, on the retaining ring, connecting the main body and arm were worn.The device did not provide any resistance when the retaining ring was rotated.If the retaining ring is loosened, the device's slide rod would be able to disengage.Device and complaint history records were reviewed and no relevant manufacturing issues were identified.However, 2 similar complaints were identified.As the device was manufactured on 29-jan-2015,it is likely that normal wear and tear contributed to this failure.
Event or Problem Description
It was reported that a luxor arm post securing mechanism dissengaged intra-operatively.There were no adverse consequences to the patient.

• 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: 9780257
• Report Number: 0009617544-2020-00034
• Device Sequence Number: 14147815
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: 07613327266177
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 04/09/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1