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

Catalog Number	48250240
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pin in the arm has fallen out when tightening to the bed.No adverse consequences to the patient has been reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via visual inspection.The arm was returned with the locking mechanism missing from the device.The locking mechanism was not returned with the rest of the arm.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The arm was reported to be used over 100 times and was found to be 5 years old at the time of the event.The instruments ifu states: "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.Great care must be taken of the instruments to ensure that they remain in good working order." conclusion: the most likely root cause is wear due to the device's extended use.
Event or Problem Description
It was reported that the pin in the arm has fallen out when tightening to the bed.No adverse consequences to the patient has been reported.

• 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: 7703742
• Report Number: 0009617544-2018-00178
• Device Sequence Number: 995590
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: 07613327266177
• Combination Product (Y/N): N
• 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): 11/19/2018

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 Catalogue Number: 48250240
• Device Lot Number: 132808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1