MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. CABLE/CRIMP PKG ASSY TI; BIOMET CABLE SYSTEM

Catalog Number SEE H10

Device Problem Break (1069)

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

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Catalog number: 14-500051 or 14-500052.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.Reference reports 3012447612-2018-00717, 3012447612-2018-00718, and 3012447612-2018-00730 thru 3012447612-2018-00731.

Event Description

It was reported that five cables were broken during installation while tension was being applied.The cables were removed and replaced without reported patient impacts.This is report three of five for this event.

Manufacturer Narrative

Expiration date: may 31, 2024 or apr 31, 2024.May 23, 2014 or may 16, 2014.The returned double cable was evaluated.Visual inspection revealed that the cable has broken.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.It is possible that the surgeon over tensioned the cable during installation as was reported by the sales representative.

Event Description

It was reported that five cables were broken during installation while tension was being applied.The cables were removed and replaced without reported patient impacts.This is report three of five for this event.

• Brand Name: CABLE/CRIMP PKG ASSY TI
• Type of Device: BIOMET CABLE 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: 7828482
• MDR Text Key: 118748289
• Report Number: 3012447612-2018-00729
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK071271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10
• Device Lot Number: 221228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/29/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1