MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS TRANSVERSE CONNECTOR 60MM; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48551071
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when torquing the transverse connector set screw, the transverse connector broke.It was the piece that snaps onto the rod that broke.The counter torque was used.All other blockers were final tightened.The set screw was removed from the connector, and the entire connector was replaced.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.Manufacturing records were reviewed and no manufacturing anomalies were reported.The visual examination confirmed a fracture overload situation.The possible root causes include: excessive tightening torque applied, previous damage to the clip during insertion.
Event or Problem Description
It was reported that; when torquing the transverse connector set screw, the transverse connector broke.It was the piece that snaps onto the rod that broke.The counter torque was used.All other blockers were final tightened.The set screw was removed from the connector, and the entire connector was replaced.

• Brand Name: OASYS TRANSVERSE CONNECTOR 60MM
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6104746
• Report Number: 0009617544-2016-00458
• Device Sequence Number: 16312477
• Product Code: KWP
• UDI-Device Identifier: 04546540596086
• UDI-Public: (01)04546540596086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• 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): 01/19/2017

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 Catalogue Number: 48551071
• Device Lot Number: PZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1