MAUDE Adverse Event Report: ZIMMER SPINE EXTENDER SLEEVE REDUCTION STYLE- LONG

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 07/08/2016

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 one of four for the same event; see also 0002184052-2016-00151, 00152 and 00153.

Event Description

The sales associate reported non-functional instruments.During a case the sleeves were unable to be used during the nxt case.It was reported that the sleeves have started to splay at the bottom, not allowing the screws to sit in the grooves correctly, therefore not letting the screwdrivers to be seated in the screw head.The surgery was completed using the short sleeves and pins.The doctor had to change technique from true percutaneous, because the short sleeves were not long enough for the obese patient, to a mini open type approach.

Manufacturer Narrative

The returned sleeve was examined.There was evidence of use (scratches) but no signs of damage or deformation.When functionally tested with mating parts, the connection between the sleeve and the pedicle screw was slightly loose, allowing the screw to wiggle slightly, but the device was operational.A review of the manufacturing records did not identify any issues which may have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding proper device usage.

• Brand Name: EXTENDER SLEEVE REDUCTION STYLE- LONG
• Type of Device: EXTENDER SLEEVE
• 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 ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5853964
• MDR Text Key: 51387818
• Report Number: 0002184052-2016-00150
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2016
• 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: 85HJ
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention