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 Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery when using the decompression tube post that comes in the set, when tightening the pin it kept going through the spring of the locking mechanism.It ultimately wouldn't tighten the post.Tried a second post and the same issue occurred.Both were used 50-100x each.The instruments weren't observed prior to the surgery because they both were used previously successfully the day before the surgery.No lubrication performed on the instruments because it was not needed.The surgeon was performing an mis discectomy and had to open the incision to use other instrumentation to complete the procedure.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual and functional inspection.The locking mechanism was returned disengaged.The threads on the set screw were damaged.Manufacturing history was reviewed and no issues were identified.The device is in the field for over 3 years and has been used at least 50-100 times.A root cause of the event is normal wear and tear.
Event or Problem Description
It was reported that; during surgery when using the decompression tube post that comes in the set, when tightening the pin it kept going through the spring of the locking mechanism.It ultimately wouldn't tighten the post.Tried a second post and the same issue occurred.Both were used 50-100x each.The instruments weren't observed prior to the surgery because they both were used previously successfully the day before the surgery.No lubrication performed on the instruments because it was not needed.The surgeon was performing an mis discectomy and had to open the incision to use other instrumentation to complete the procedure.

• 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: 6843657
• Report Number: 0009617544-2017-00350
• Device Sequence Number: 18843317
• Product Code: LXH
• UDI-Device Identifier: 07613327266177
• UDI-Public: (01)07613327266177(11)140618(10)142630
• Combination Product (Y/N): N
• 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): 11/30/2017

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: 08/25/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1