MAUDE Adverse Event Report: FEN MIS CANNULA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 279726508

Device Problems Break (1069); Component Incompatible (1108); Difficult to Insert (1316); Malposition of Device (2616)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Complaint not reportable.Cannula, fenestrated screw mis (p/n 279726508) is not approved for market in the u.S.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Revision of viper 2 unilateral, cfx screw and confidence cement, l3-iliac crest.Dr kam was inserting a 10x80mm cfx screw using his custom made screwdriver (b)(4).Screws of this diameter and length are not standard.This screw was being placed across the sacral-iliac joint so therefore needed to be longer than a standard pedicle screw.As it was a revision case the screw diameter needed to be greater than the screw that was removed (7.5 x 100mm).The screw was being inserted and everything was fine whilst the dual lead was going into the bone.The torsion increased when the quad lead portion of the screw was reached.Dr (b)(6) was advised that he needed to insert the screw much more slowly because of the additional torsion.There was a click and the screw driver tip (the t20) had broken, the screw wasn¿t able to be inserted any further.Half of the t20 interface had sheared off and remained in the cannulation of the screw that is in the patient.Attempts were made to retrieve it without success.Dr (b)(6) made the decision to leave the small fragment inside the screw.The remaining screws were placed without difficulty.He attempted to inject cement through the cfx mis cannula without using the cfx mis extension, had been able to pass the cannula around the side of the broken screwdriver tip.This caused the cfx mis cannula tip to snap.The cannula fragment was retrieved.The rest of the procedure was completed: rod was placed & the set screws, construct was final tightened.

• Brand Name: FEN MIS CANNULA
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4635012
• MDR Text Key: 21852626
• Report Number: 1526439-2015-10227
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 279726508
• Device Lot Number: 5104664
• Date Manufacturer Received: 03/03/2015
• Patient Sequence Number: 1