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

Model Number 48250240

Device Problems Accessory Incompatible (1004); Mechanical Problem (1384); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

The sales representative reported that the two retractor arm posts were inspected and free of any visible damage.The two arm posts were taken apart and the issues were still not resolved after putting them back together.A supplemental report will be provided upon completion of the investigation.

Event Description

It was reported that the retractor arm post would not tighten to the bed in the operating room.A back up arm post was also slipping when trying to tighten and eventually failed as well.The procedure was completed successfully with a third post.There was no delay in surgery or adverse consequences to the patient.

Event Description

It was reported that the retractor arm post would not tighten to the bed in the operating room.A back up arm post was also slipping when trying to tighten and eventually failed as well.The procedure was completed successfully with a third post.There was no delay in surgery or adverse consequences to the patient.

• Brand Name: LUXOR ARM POST
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7278058
• MDR Text Key: 100523855
• Report Number: 0009617544-2018-00043
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: (01)07613327266177
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48250240
• Device Catalogue Number: 48250240
• Device Lot Number: 10E067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1