MAUDE Adverse Event Report: STRYKER SPINE-US ANCHOR C DIAM 3.5MM SELF DRILLING 10MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	48335310
Medical Device Problem Codes	Fracture (1260); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor c self drilling bone screw 'did not fit in proper position' intra-operatively.No adverse consequences, surgical delay or medical intervention were reported. the procedure was completed successfully.
Additional Manufacturer Narrative
Section d4: catalog number and gtin have been changed from "48335310" and " 04546540679833" to "6741610" and "07613327487992" following the dhr review visual inspection was performed on the returned screw.Marks on the screw indicate that the user may have experienced difficulty during the procedure.Locking ring of the screw was fractured and the locking ring was protruding from the screw head.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Per correspondence, no damage was noticed prior to insertion of the screw, it is unknown if the inserter was taken off at any time, it is unknown if excessive force was used or if the screw was implanted at difficult angle.Patient anatomy and screw hole preparation is also unknown.Per the anchor c surgical technique: to ensure proper depth and adequate locking when using the awl, drilling, or locking bone screws, use of a free hand technique is strongly discouraged.Use of the guide/inserter tip or low profile inserter is required.The inserter may separate slightly from the cage throughout the procedure.A gap between the cage and inserter may result in improper seating of the screw.Prior to screw insertion, ensure the inserter is flush to the cage.Excessive pivoting or angulation on the screwdriver while attached to the screw should be avoided as it can cause damage to the screwdriver and/or screw.The cause of the reported event cannot be determined conclusively from the information provided.However, potential root causes for locking ring fracture/difficulty with locking the screw include: challenging patient anatomy, inadequate preparation of screw hole, inserter incorrectly aligned with cage (may cause inserter loosening during surgery), and gap between the inserter and the cage.
Event or Problem Description
It was reported that the anchor c self drilling bone screw 'did not fit in proper position' intra-operatively.No adverse consequences, surgical delay or medical intervention were reported. the procedure was completed successfully.

• Brand Name: ANCHOR C DIAM 3.5MM SELF DRILLING 10MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11843068
• Report Number: 3005525032-2021-00020
• Device Sequence Number: 4662889
• Product Code: OVE
• UDI-Device Identifier: 04546540679833
• UDI-Public: 04546540679833
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102606
• 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): 10/11/2021

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: 48335310
• Device Catalogue Number: 6741610
• Device Lot Number: 2KM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 10/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR