MAUDE Adverse Event Report: ZIMMER SPINE C-SHAPE SLEEVE RDCTN STYLE

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report three of four for the same event; see also 0002184052-2016-00075, 00076 and 00078.

Event Description

The sales associate reported that a percutaneous screw placement l4-l5 with listhesis gr.1 -rod insertion 50mm - direction cranial to caudal.Caudal set screw insertion was performed.It is reported the physician was very gentle with the set screw driver, no force was used however the set screw thread broke spontaneously.The physician removed the set screw first, then removed the rod and removed the screw.Another screw was placed using another extender sleeve and the same rod was used to complete the surgery without any further issues.

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.Fields were updated based on the receipt of the device for evaluation.Report three of four for the same event, reference 0002184052-2016-00076-1, 00076-1 and 00078-1.

Manufacturer Narrative

The returned device was examined and to have deformed and fractured threads.The complaint is confirmed.There were no manufacturing issues detected which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding device usage.

• Brand Name: C-SHAPE SLEEVE RDCTN STYLE
• Type of Device: 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: teresa george ; 7375 bush lake road; minneapolis, MN 55439
• MDR Report Key: 5707243
• MDR Text Key: 46854628
• Report Number: 0002184052-2016-00077
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3557-1300
• Device Lot Number: 69JH
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2011
• Is the Device Single Use?: Yes
• 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): Hospitalization; Required Intervention