MAUDE Adverse Event Report: ZIMMER SPINE SEQUOIA CLOSURE TOP

Model Number N/A

Device Problem Device Damaged by Another Device (2915)

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

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.Two devices were returned that were not reported, the complainant confirmed they were part of this event.Report four of four for the same event, reference 0002184052-2016-00044-1, 0002184052-2016-00045-1, and 0002184052-2016-00201.

Event Description

It is reported two screws fractured during the operation.There was no injury to the patient, the screws were removed and replaced during the same operation.

Manufacturer Narrative

The returned closure tops were examined and found that some of the threads had sheared off in a manner consistent with cross-threading the devices during assembly.The complaint is confirmed.There were no indications of manufacturing issues which would have contributed to this event.The labeling was reviewed and found to have instructions regarding proper assembly.

• Brand Name: SEQUOIA CLOSURE TOP
• Type of Device: CLOSURE TOP
• 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 ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 5925100
• MDR Text Key: 53828976
• Report Number: 0002184052-2016-00202
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: PK131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• 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: 3301-1
• Device Lot Number: 84GC
• 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?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2015
• Is the Device Single Use?: Yes
• 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