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 Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that the c-ring of an anchor c screw detached during insertion.The procedure was completed successfully with a five-minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device and the locking ring is fractured as was reported.Functional analysis cannot be performed because, without the locking ring, the device is no longer functional.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Anchor c surgical technique indicates: 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.One of the possible root causes identified was freehand use during screw insertion.The cause of the reported event cannot be determined conclusively from the information provided.
Event or Problem Description
A company representative reported that the c-ring of an anchor c screw detached during insertion.The procedure was completed successfully with a five-minute surgical delay and no adverse consequence to the patient.

• 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: 11814345
• Report Number: 3005525032-2021-00019
• Device Sequence Number: 3224354
• 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): 09/10/2021

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: 48335310
• Device Lot Number: 2WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR