MAUDE Adverse Event Report: ZIMMER SPINE PATHFINDER NXT (PEDICAL SCREW SYSTEM); EXTENDER SLEEVE REDUCTION LONG

Model Number N/A

Device Problem Device Operational Issue (2914)

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

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Report two of two for the same event, reference 0002184052-2016-00239.

Event Description

It was reported when the surgeon advanced the closure top for final torque, however final tightening was not allowable because threads on closure top sheared off.It is believed the extension sleeve dissociated from the screw head causing threads to jump, and eventually shear off.The surgeon tried another closure top but had the same results.It was a 2 level construct and closure top threads sheared off during the final torque in the middle level of the contralateral side.The surgeon torqued off the top and bottom of the construct as well as the three screws on the ipselateral side.There were 5 points of fixation, so the surgeon was comfortable leaving the middle screw on the contralateral side open.The surgery was completed, there was a fifteen minute delay and the patient did not retain a foreign body.

Manufacturer Narrative

The returned sleeve was evaluated.It was functionally checked with mating components and found to operate as expected; the complaint cannot be confirmed for the sleeve.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: PATHFINDER NXT (PEDICAL SCREW SYSTEM)
• Type of Device: EXTENDER SLEEVE REDUCTION LONG
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5987067
• MDR Text Key: 55923152
• Report Number: 0002184052-2016-00240
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3557-2300
• Device Lot Number: 84PE
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention