MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 10MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48335310
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	06/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; ring on screw came off during insertion.Drill guides were not used-screws were free-handed.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment; results: causes of the event are: freehand use during screw insertion, inserter loosening during surgery, inserting not fully threading, user unfamiliar with system, interaction between cage/screw/inserter, outer diameter of clip is too large, conclusion: the established cause of the event is general use error.
Event or Problem Description
It was reported that; ring on screw came off during insertion.Drill guides were not used-screws were free-handed.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 10MM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5799809
• Report Number: 3005525032-2016-00084
• Device Sequence Number: 604759
• Product Code: OVE
• UDI-Device Identifier: 04546540679833
• UDI-Public: (01)04546540679833
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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): 06/21/2016

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 Catalogue Number: 48335310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 09/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1