MAUDE Adverse Event Report: STRYKER SPINE-US OASYS TRANSVERSE CONNECTOR; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	48551070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transverse connector broke during tightening.It was reported that the surgeon was using the final tightener without the use of the anti-torque.Surgery was completed successfully.No adverse consequence to the patient was reported.
Additional Manufacturer Narrative
Additional information: lot number.Method: visual inspection, risk assessment, product history review, labeling review.Results: the returned clip was visually confirmed to be fractured.The clip is no longer functional.Materials analysis was not performed as the representative confirmed the lack of use of the anti-torque with the final tightener.Product history review was conducted.No relevant manufacturing issues were identified.Conclusion: surgical technique guide warns that the torque wrench must be used during final tightening of the connector set screws and that the recommended value is to apply 3nm to the blockers when using the torque wrench.Since it was reported that the final tightener was used instead of the torque wrench, the probable root cause of the clip fracture is the lack of use of the torque wrench.
Event or Problem Description
It was reported that the transverse connector broke during tightening.It was reported that the surgeon was using the final tightener without the use of the anti-torque.Surgery was completed successfully.No adverse consequence to the patient was reported.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8048498
• Report Number: 0009617544-2018-00262
• Device Sequence Number: 1586190
• Product Code: KWP
• UDI-Device Identifier: 04546540371607
• UDI-Public: 04546540371607
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/24/2018

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 Catalogue Number: 48551070
• Device Lot Number: U2E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1