MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.4.0MM SELF DRILLING 10MM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number	48335410
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon noticed the ring on a 4.0 x 10 sd screw was broken as he was inserting into the implant.
Additional Manufacturer Narrative
Method: risk assessment; results: the screw was not returned for evaluation and no lot# was provided.Therefore device history, complaint history and device inspection could not be performed.Conclusion: the root cause could not be determined conclusively.
Event or Problem Description
It was reported that the surgeon noticed the ring on a 4.0 x 10 sd screw was broken as he was inserting into the implant.

• Brand Name: ANCHOR C DIAM.4.0MM 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: 6254413
• Report Number: 3005525032-2017-00010
• Device Sequence Number: 13659972
• Product Code: OVE
• UDI-Device Identifier: 04546540679871
• UDI-Public: (01)04546540679871
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K102606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2017

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: 48335410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 03/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1