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 No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2017

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.

Event Description

It was reported that the tip of an inserter broke off while attempting to attach the inserter to the mating spacer during surgery.An alternative instrument was used to complete the procedure.There were no reports of patient impacts associated with this event.

Manufacturer Narrative

Additional information: the returned inserter was examined.One of the two prongs was confirmed to have fractured off.As only one tine fractured off, it is likely that an off-axis force may have been applied while attempting to connect the inserter to the implant.The condition of the device prior to surgery is unknown.It is possible that one of the tines had experienced a shear force in a previous case which weakened the base of the tine and led to its eventual fracture once a shear force was applied again during this case.A review of the manufacturing records did not identify any issues which would have contributed to 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7148261
• MDR Text Key: 95846794
• Report Number: 3012447612-2017-00701
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PK112014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14-534900
• Device Lot Number: 035388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2011
• 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