MAUDE Adverse Event Report: STRYKER SPINE-US OASYS BLOCKER; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48551000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an oasys blocker was observed to be stripped on an mri one year post-operatively.Revision surgery has occurred and the blocker has been removed.
Event or Problem Description
It was reported that an oasys blocker was observed to be stripped on an mri one year post-operatively.Revision surgery has occurred and the blocker has been removed.
Additional Manufacturer Narrative
Visual inspection: the hex shape of the inner blocker was stripped and deformed consistent with excessive torsional force.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per oasys surgical technique: once all of the blockers have been inserted, the insertion tube or the persuader, in combination with the torque wrench or audible torque wrench, should be used for final tightening.The blocker is completely tightened when the two arrows on the shaft of the torque wrench are aligned, which corresponds to 3nm.The blocker is completely tightened to 3nm when the audible torque wrench clicks once.The audible torque wrench must be disposed of after use in surgery.It cannot be sterilized.It is important to tighten the blocker to the recommended torque to ensure future integrity of the construct.Tightening under or over the torque limit is inadvisable and should be avoided.Appropriate counter-torque must be applied with the insertion tube or persuader.Based on the deformation seen on the blocker, the most likely root cause is excessive torsional force applied during the initial insertion.

• Brand Name: OASYS BLOCKER
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10283337
• Report Number: 0009617544-2020-00124
• Device Sequence Number: 485485
• Product Code: NKG
• UDI-Device Identifier: 04546540371508
• UDI-Public: 04546540371508
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2020

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: Health Professional
• Device Model Number: 48551000
• Device Catalogue Number: 48551000
• Device Lot Number: 454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 117