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	Detachment Of Device Component (1104); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during an acdf case, we were implanting a self drilling screw into a 6 mm height stand alone cage.As the surgeon inserted the screw into the bone, a small black ring popped off the top of the screw.As i had never seen this before, i was unsure what it was but advised the surgeon to remove the screw and replace it with a rescue self drilling bone screw.The hospital administrator removed the screw and the black ring piece that popped off from the sterile field and placed it in a specimen cup.
Additional Manufacturer Narrative
Method: risk assessment; results: the screw was not returned for evaluation (kept by the hospital) therefore, device inspection, device history review and complaint history review could not be performed.Conclusion: the plausible root cause of the reported event is most likely inserting the screw at difficult angle.
Event or Problem Description
It was reported that; during an acdf case, we were implanting a self drilling screw into a 6 mm height stand alone cage.As the surgeon inserted, the screw into the bone, a small black ring popped off the top of the screw.As i had never seen this before, i was unsure what it was but advised the surgeon to remove the screw and replace it with a rescue self drilling bone screw.The hospital administrator removed the screw and the black ring piece that popped off from the sterile field and placed it in a specimen cup.

• 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: 6458252
• Report Number: 3005525032-2017-00044
• Device Sequence Number: 590951
• Product Code: OVE
• UDI-Device Identifier: 04546540679833
• UDI-Public: (01)04546540679833
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/09/2017

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: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1