MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 12MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48335312
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; surgeon had difficulty removing screws from cage.
Additional Manufacturer Narrative
Lot# bwm; visual inspection; device history review; complaint history review; risk assessment.No relevant manufacturing issues were identified as all units met stryker specifications.Visual inspection confirmed the screw was returned separated from the cage.The plausible root cause of the reported event is user error, specifically inserting the screw too deep.
Event or Problem Description
It was reported that; surgeon had difficulty removing screws from cage.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 12MM
• 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: 6445573
• Report Number: 3005525032-2017-00042
• Device Sequence Number: 19051071
• Product Code: OVE
• UDI-Device Identifier: 04546540679840
• UDI-Public: (01)04546540679840
• Combination Product (Y/N): N
• 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): 06/15/2017

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: 48335312
• Device Lot Number: BWM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/02/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1