MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO LX SMALL CONNECTOR; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48902015
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	02/15/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; during surgery, the surgeon used the screw and connector for th12 vertebral body fracture.The surgeon removed the connector adapter from offset connector of th12(left) and l1.To remove the connector adapter from offset connector of th12 (right), the surgeon tried to loosen nut, but it was not possible to loosen nut.Therefore, the surgeon tried to loosen the offset connector of l1(left) and remove the rod.However, it was not possible to loosen the set screw of offset connector.The surgeon used the rod cutter.And he used brand-new screw and the offset connector.Operation time was exceeded for about 3 hours.
Additional Manufacturer Narrative
Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the connector was received with a jammed set with visibly worn hex corners.The worn nature of the hex suggests that the corresponding hex tip was forcibly rotated while the set screw remained stationary, which confirms that the set screw was jammed in the offset connector.Conclusion: review of a similar complaint involving a jammed offset connector reveals that the jamming occurred due to galling of the connector and biological particles lodged between the offset connector and set screw threads which is likely cause of this event.
Event or Problem Description
It was reported that; during surgery, the surgeon used the screw and connector for th12 vertebral body fracture.The surgeon removed the connector adapter from offset connector of th12 (left) and l1.To remove the connector adapter from offset connector of th12 (right), the surgeon tried to loosen nut, but it was not possible to loosen nut.Therefore, the surgeon tried to loosen the offset connector of l1 (left) and remove the rod.However, it was not possible to loosen the set screw of offset connector.The surgeon used the rod cutter.And he used brand-new screw and the offset connector.Operation time was exceeded for about 3 hours.

• Brand Name: TRIO LX SMALL CONNECTOR
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5490417
• Report Number: 0009617544-2016-00112
• Device Sequence Number: 10940417
• Product Code: MNH
• UDI-Device Identifier: 04546540494160
• UDI-Public: (01)04546540494160
• Combination Product (Y/N): N
• PMA/510(K) Number: K070368
• 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): 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 48902015
• Device Lot Number: 156418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 05/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 YR