MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. RETRACTOR TOP LEVEL ASSM

Catalog Number 8734-0010

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Udi number: ni.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference report 3012447612-2019-00098.

Event Description

It was reported that two retractor bodies were found with stripped screws after post-operative cleaning.There were no reported surgical or patient impacts.This is report one of two for this event.

Manufacturer Narrative

Additional information: results, and conclusions - the device was not returned for evaluation, so no results are available and no conclusions can be drawn.The lot number is unknown; therefore the device history records are unable to be reviewed.

Event Description

It was reported that two retractor bodies were found with stripped screws after post-operative cleaning.There were no reported surgical or patient impacts.This is report one of two for this event.

• Brand Name: RETRACTOR TOP LEVEL ASSM
• 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: 8375982
• MDR Text Key: 137375724
• Report Number: 3012447612-2019-00097
• 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: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8734-0010
• Was Device Available for Evaluation?: No
• 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?: Device Not Returned to Manufacturer
• 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