MAUDE Adverse Event Report: STRYKER SPINE-US OASYS CROSS NUT TIGHTHENER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48561075
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during installation of connector and torque wrench, connection was loose and surgeon was not able to perform final tightening.The connector could not be removed from the torque wrench.It is unclear how much the doctor could tighten the screw.There are no reports of adverse health consequences.
Event or Problem Description
It was reported that during installation of connector and torque wrench, connection was loose and surgeon was not able to perform final tightening.The connector could not be removed from the torque wrench.It is unclear how much the doctor could tighten the screw.There are no reports of adverse health consequences.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, product history review, complaint history review, labelling review, risk assessment.Conclusion: the instruments were returned for evaluation and the reported issue was confirmed based on visual and functional inspection.The surgical technique suggests using the cross connector nut inserter to ensure the nuts of the cross connector plate are seated appropriately so that the cross connector nut tightener and torque wrench construct can final tighten the nuts.Also, instruments should be lubricated and maintained properly to ensure proper use of the device.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.It is inconclusive how many times the instrument has been used.The instrument was manufactured in march 2013 and is approximately 5 years old.The plausible root cause of the reported event was determined to be normal wear and tear due to the age of the instrument.

• Brand Name: OASYS CROSS NUT TIGHTHENER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7474271
• Report Number: 0009617544-2018-00093
• Device Sequence Number: 1216408
• Product Code: LXH
• UDI-Device Identifier: 07613327271577
• UDI-Public: (01)07613327271577
• 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
• Report Date (Section B): 07/24/2018

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: Health Professional
• Device Model Number: 48561075
• Device Catalogue Number: 48561075
• Device Lot Number: 133669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR