MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PLUG STARTER WITH FIXED HANDLE; SCREWDRIVER

Catalog Number 14-500170

Device Problem Device Fell (4014)

Patient Problem Spinal Cord Injury (2432)

Event Date 07/25/2014

Event Type  Injury  

Manufacturer Narrative

Udi number: na.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.

Event Description

It was reported that a plug starter slipped out of the surgeon's hand during a procedure and landed on the patient's spinal cord.The patient lost motor signals on the left side so the implants were removed and the procedure was aborted.It was reported that the patient regained motor signals after the procedure was completed.

Manufacturer Narrative

Additional information: results and conclusion - 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.Current information is insufficient to permit a valid conclusion about the cause of this event.

Event Description

It was reported that a plug started slipped out of the surgeon's hand during a procedure and landed on the patient's spinal chord.The patient lost motor signals on the left side, so the implants were removed and the procedure was aborted.It was reported that the patient regained motor signals after the procedure was completed.

• Brand Name: PLUG STARTER WITH FIXED HANDLE
• Type of Device: SCREWDRIVER
• 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: 8349775
• MDR Text Key: 136475216
• Report Number: 3012447612-2019-00084
• Device Sequence Number: 1
• Product Code: HXX
• 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: consumer,distributor,health p
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14-500170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/10/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR