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

Model Number	48250240
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the post for tubes broke.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: the device was inspected and the locking rod was returned disengaged from the arm post body.A functional inspection was performed and the reported event was confirmed.The arm post is not functional after reassembly.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Conclusion: since the reported complaint device was in the market for around 3.5 years.The most likely cause of the reported event was determined to be normal wear and tear.
Event or Problem Description
It was reported that the post for tubes broke.

• Brand Name: LUXOR ARM POST
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7033251
• Report Number: 0009617544-2017-00411
• Device Sequence Number: 978075
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: (01)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): 01/23/2018

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: 142630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1