MAUDE Adverse Event Report: STRYKER SPINE-US OASYS TRANSVERSE CONNECTOR; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	48551070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the transverse connector broke at the time of final tightening of blocker with torque wrench.Blocker was in inside of transverse head.The surgeon changed it with a new one and surgery succeeded.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Device was returned.
Event or Problem Description
It was reported that the transverse connector broke at the time of final tightening of blocker with torque wrench.Blocker was in inside of transverse head.The surgeon changed it with a new one and surgery succeeded.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence with the sales representative, as well as visual inspection of the returned device.The procedure was completed successfully with an alternate device.No surgical delay and no patient harm was reported.Surgical technique warns that the torque wrench must be used during final tightening of the connector set screws.The recommended value is to apply 3nm to the blockers when using the torque wrench.The transverse bar is available in various sizes and can be cut to specific patient anatomy.Manufacturing records were reviewed and no relevant manufacturing issues were identified.It was determined that the lot was manufactured in august 2009 and is approximately 9 years old.Conclusion: the plausible root cause of the reported event could be determined conclusively to be normal wear and tear due to the age of the device.The user could have also applied too much torque or the disposable torque driver could have been used past its life expectancy.
Event or Problem Description
It was reported that the transverse connector broke at the time of final tightening of blocker with torque wrench.Blocker was in inside of transverse head.The surgeon changed it with a new one and surgery succeeded.There are no reports of adverse health consequences to the patient.

• Brand Name: OASYS TRANSVERSE CONNECTOR
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7551260
• Report Number: 0009617544-2018-00113
• Device Sequence Number: 1899285
• Product Code: NKG
• UDI-Device Identifier: 04546540371607
• UDI-Public: (01)04546540371607
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/26/2018

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 Model Number: 48551070
• Device Catalogue Number: 48551070
• Device Lot Number: U2G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 06/29/2018; 07/30/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 07/11/2018; 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1