MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ZYSTON STRAIGHT INLINE INSERTER; ZYSTON STRAIGHT SPACER SYSTEM

Catalog Number 14-534900

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/27/2018

Event Type  Injury  

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.

Event Description

It was reported that the tip of an inserter broke off during implant installation within surgery.The tip was not removed from the wound since it is close to a nerve.There have not been any reported patient impacts associated with this event.

Manufacturer Narrative

Udi number: na.The returned inserter was evaluated.One of the tines has fractured off of the device.There were no other signs of damage on the device.It is likely that off-axis forces during insertion of the implant cause the tine to fracture off.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

Event Description

It was reported that the tip of an inserter broke off during implant installation within surgery.The tip was not removed from the wound since it is close to a nerve.There have not been any reported patient impacts associated with this event.

• Brand Name: ZYSTON STRAIGHT INLINE INSERTER
• Type of Device: ZYSTON STRAIGHT SPACER SYSTEM
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7763707
• MDR Text Key: 116448748
• Report Number: 3012447612-2018-00624
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK112014
• 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: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-534900
• Device Lot Number: 038085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other