MAUDE Adverse Event Report: DEPUY SYNTHES SPINE MNTR INNER SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 188342200

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Operative plan: place lateral mass screws at c1-c2 with rods to support a bilateral fx of c1 ring.Dr (b)(6) felt a crosslink was a must due to the bilateral fx and lack of rotational support and displacement of c1 ring.End result: screws at c1-c2 were placed with rods connecting the screws.Dr (b)(6) chose to close without a crosslink due to the failure of our crosslink nut and cap interface.Steps taken during implant failure: resident (b)(6) placed crosslink inner screw in the tulip head and torqued the inner screw down.A crosslink was placed and a nut put on to hold down.When trying to torque the nut down, the nut sheared the threads from the inner set screw causing it to strip.This process repeated a second time for (b)(6).-3rd attempt dr (b)(6) tried and the same result happened.We had now stripped the threads off of 3 inner screws and attempted with 3 new nuts.Dr (b)(6) changed to a longer crosslink.We attempted to go back and forth tightening the nuts down a little at a time on each side.We were able to get the right side to lock down and the nut to torque.However, on the left side, we had the same problem of the nut stripping the threads of the set screw.We tried the left side twice with same outcome.After the second attempt to torque the nut on the left side, dr (b)(6) noticed the screw on the right side was moving freely on the rod.He then needed to remove the only side we could get to torque as it too appeared to be defective.The threads on the inner screw that went into the tulip head of the screw appeared to be damaged causing it to not lock down properly even though the driver would torque.We then tried 3 more times to get a nut to lock down the crosslink.The same outcome of the nut stripping the threads from the inner screw occurred.At this point, dr (b)(6) made the decision to close the patient without a crosslink due to the failure of our hardware.

Manufacturer Narrative

Additional narrative: a complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available for investigation.

Manufacturer Narrative

The mountaineer inner screw (product code: 1883-42-200) was not returned to the complaints handling unit (chu).A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.Without the screw we are unable to confirm the reported issue or identify the root cause.If the device returned at a later date, the complaint will be reopened and the sample will be evaluated.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not available for investigation.

• Brand Name: MNTR INNER SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767 CH-
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 4802685
• MDR Text Key: 5926121
• Report Number: 1526439-2015-10493
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK041203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 188342200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1