MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POLYAXIAL HEX SCREW DRIVER (2.5MM); SCREWDRIVER

Catalog Number 07.01764.002

Device Problems Fracture (1260); Failure to Disconnect (2541)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

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.

Event Description

It was reported that a driver shaft was difficult to remove from the mating screw after the screw was installed during surgery.Additional information has been requested, but has not been provided.

Manufacturer Narrative

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 a polyaxial screwdriver that broke into 2 pieces while installing a screw during surgery.There were no patient or surgical impacts.

Manufacturer Narrative

Udi: na.Additional information: (methods, results, and conclusions) - the returned screwdriver was evaluated.The device shaft has fractured.It is possible that when the screw was being installed, and off axis force was applied which caused the fracture.It is also possible that the driver had weakened from previous uses and the forces exerted during this case exceeded the mechanical capabilities of the device.A review of the manufacturing records did not identify any issues which would have contributed to this event.

Event Description

It was reported a polyaxial screwdriver that broke into 2 pieces while installing a screw during surgery.There were no patient or surgical impacts.

• Brand Name: POLYAXIAL HEX SCREW DRIVER (2.5MM)
• 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: 8352145
• MDR Text Key: 136618251
• Report Number: 3012447612-2019-00090
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.01764.002
• Device Lot Number: 63486322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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