MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POSTERIOR BLADE LATERAL RETRACTOR 120MM

Catalog Number 8734-5120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that a shim disassembled from a blase assembly.It is unknown when the shim disassembled but was discovered outside of surgery.

Manufacturer Narrative

Additional information: (method, results, conclusions) - the returned retractor blade was evaluated.It was found that the shim has disassembled from the device.There were no other signs of damage on the device.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.The event is stated to have occurred outside of surgery; however, the specific details concerning the shim insertion and removal are unavailable despite due diligence.As such, the cause cannot be conclusively determined.Failures of this nature are often attributed to greater than expected forces being used during either the shim insertion or removal process causing the shim the detach from the blade.

Event Description

It was reported that a shim disassembled from a blase assembly.It is unknown when the shim disassembled but was discovered outside of surgery.

• Brand Name: POSTERIOR BLADE LATERAL RETRACTOR 120MM
• Type of Device: RETRACTOR
• 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: 8379837
• MDR Text Key: 137514912
• Report Number: 3012447612-2019-00096
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8734-5120
• Device Lot Number: IG21781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2013
• 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