MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L DRILL 5MM MODULAR RIGID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48999150
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cage inserted 5mm rigid drill bit advanced to positive spot.After a few turns counterclockwise to remove drill bit it broke of in the vertebral body.The surgeon attempted to remove the cage but was unsuccessful.The drill bit was left in the vertebral body.Two additional screws were implanted.Locking plate fixed.
Additional Manufacturer Narrative
Device history review; complaint history review; risk assessment; no product was returned therefore the device inspection could not be performed.No relevant manufacturing issues were found upon manufacturing history review.According to the referenced risk file, user applying too much pulling force may break the tip.Material analysis performed on a previous similar complaint concluded that device fractured under applied torsional force.Additionally the device was found to be almost 3 years old, it is unknown how many times it has been used as it is reported to be a loaner device.The root cause of this event cannot be determined conclusively and is multifactorial.
Event or Problem Description
It was reported that the cage inserted 5mm rigid drill bit advanced to positive spot.After a few turns counterclockwise to remove drill bit it broke of in the vertebral body.The surgeon attempted to remove the cage but was unsuccessful.The drill bit was left in the vertebral body.2 additional screws were implanted.Locking plate fixed.

• Brand Name: ANCHOR L DRILL 5MM MODULAR RIGID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5784148
• Report Number: 0009617544-2016-00282
• Device Sequence Number: 639311
• Product Code: LXH
• UDI-Device Identifier: 07613327275087
• UDI-Public: (01)07613327275087
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 06/16/2016

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: 48999150
• Device Lot Number: 138260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 10/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1