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

Model Number	48250240
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the arm post was no attaching to the bed during a procedure.Another pan with a back up arm post was used to complete the procedure.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via functional inspection.The luxor arm was attached to the table and tightened down, but was still noticeably loose on the table.The securing mechanism spring is most likely worn out, causing the insecure connection.Manufacturing history was reviewed and no issues were identified.The device is over 9 years old at the time of the event.Conclusion: according to the instructions for use, the life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.As the device was over 9 years old, the most likely root cause is wear due to extended use.
Event or Problem Description
It was reported that the arm post was no attaching to the bed during a procedure.Another pan with a back up arm post was used to complete the procedure.There are no reports of 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: 7455570
• Report Number: 0009617544-2018-00088
• Device Sequence Number: 1575162
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: (01)07613327266177
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2018

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: No Information
• Device Model Number: 48250240
• Device Catalogue Number: 48250240
• Device Lot Number: 08C118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1