MAUDE Adverse Event Report: BIOMET MICROFIXATION 90 DEGREE CONTRA ANGLE SCREWDRIVER; SCREW DRIVER

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00823.

Event Description

It was reported the gears stripped in two drivers during a rib plating procedure.The surgical technique for the product was utilized.The event did not result in a delay or injury to the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The drivers were visually evaluated and found to be in good overall condition; some discoloration was observed.The knob rotates with some friction on both drivers.The drivers were functionally tested by driving a screw into a white oak block and were found to insert the screw with difficulty due to the friction felt when turning the knob.The drivers were disassembled and found to have significant discoloration and stripped gear teeth.If additional torque is applied after the screw is seated it is possible that the internal gearing of the driver can be overcome.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00823-1.

• Brand Name: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Type of Device: SCREW DRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 7064606
• MDR Text Key: 93617965
• Report Number: 0001032347-2017-00822
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK142823
• 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: 04/25/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 488010
• Other Device ID Number: (01)00841036123130(10)488010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 04/10/2018
• Supplement Dates FDA Received: 04/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1