MAUDE Adverse Event Report: ZIMMER SPINE C-SHAPE SLEEVE LOCKER 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 two of four for the same event; see also 0002184052-2016-00150, 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 lock pins were examined.There were no signs of visual deformities or discrepancies.They were functionally checked with mating extender sleeves and pedicle screws ,and were found to function properly.A review of the manufacturing records did not identify any issues that would have contributed to this event.No product failures were detected; the complaint could not be confirmed.

Manufacturer Narrative

Review of this file found that this device was incorrectly reported.There was not an allegation of malfunction associated with this device and subsequent device evaluation did not find any device malfunctions.

• Brand Name: C-SHAPE SLEEVE LOCKER LONG
• Type of Device: SLEEVE LOCKER
• 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: 5853966
• MDR Text Key: 51387772
• Report Number: 0002184052-2016-00151
• 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,Followup
• Report Date: 08/14/2017

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: 3557-0001
• Device Lot Number: UNKNOWN
• 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: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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