MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CLAMP, SPINOUS PROCESS SHORT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734716

Device Problem Mechanical Problem (1384)

Patient Problems Spinal Column Injury (2081); Iatrogenic Source (2498)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A medtronic representative reported that, while in a spinal fusion, the spine clamp could not be removed from the spinous process of the patient.To remove the clamp, the portion of the spinous process was removed.It was noted that the surgeon experienced difficulties opening and closing the clamp prior to initial placement on the spinous process.The representative recommend the surgeon use a different clamp, but the surgeon elected to use the clamp.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.

Manufacturer Narrative

The reported issue was evaluated by a cross-department team at medtronic.Excess torque can force the washer to dislodge.Once the washer is dislodged, the clamp screw can be fully disengaged from the instrument.If the washer is disengaged, but the clamp screw is threaded into the instrument, the clamp screw will function for spine clamp application to the spinous process, but the lack of a washer will prevent the clamp from opening.Based on the results of the tests, it can be concluded that the root cause of the failure occurs when the spine clamp¿s drive mechanism is opened to the design travel limits, and then the clamp screw is further torqued in an attempt to open beyond the travel limits and a torque of greater than or equal to 2.72 nm is applied.

• Brand Name: CLAMP, SPINOUS PROCESS SHORT
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6748487
• MDR Text Key: 81227605
• Report Number: 1723170-2017-03100
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00643169936294
• UDI-Public: 00643169936294
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physical Therapist
• Device Catalogue Number: 9734716
• Device Lot Number: 160707
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 91