MAUDE Adverse Event Report: ZIMMER SPINE SEQ POLY SCREW ASSY 5.5 X 40

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

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 two of two for the same event; see also 0002184052-2016-00143.

Event Description

The sales associate reported receiving mislabeled product.The trinica select cervical plate package ((b)(4)), which had a sequoia screw ((b)(4)) in it.No surgery was involved.

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 0002184052-2016-00143-1.

Manufacturer Narrative

The returned device was examined.It was confirmed that the package label did not match the contents within the package.During the packaging process, an incorrect device (pedicle screw) was mixed in with the correct devices (cervical plates).Internal measures were taken to review and correct existing inventory.Investigation found no further, related packaging non-conformances and determined the issue to be an isolated event.

• Brand Name: SEQ POLY SCREW ASSY 5.5 X 40
• Type of Device: SCREW
• 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: 5825835
• MDR Text Key: 50539034
• Report Number: 0002184052-2016-00144
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131980
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3306-5540
• Device Lot Number: 86BK
• Other Device ID Number: (01)00889024334953(10)86BK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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