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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product-contra angle temporary fixation screw catalog #: 76-0017 lot: ni, therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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: 0001032347-2017-00834.

Event Description

It is reported a contra angle driver had a temporary fixation pin get stuck inside of it during a rib fixation procedure.The event resulted in a delay of five minutes.The surgery was completed with another device.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: multiple supplemental mdr reports were filed for this event, please see associated report: 0001032347-2017-00834-1.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The driver was visually evaluated and found to be in good overall condition; some discoloration was observed.The knob rotates with friction felt in a few places during one full rotation.The driver was disassembled and found to have discoloration in the gearing and stripped gear teeth.There is a broken temporary fixation screw still inserted into the driver.The fixation screw has a transverse fracture through the first minor diameter, which is typical from over torqueing.The fixation screw was able to be removed from the driver with some difficulty, and there is minor damage to the connection that locks into the driver collet.The device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event of the driver not rotating was due to excessive force.Investigation results concluded that the reported event of the stuck blade was due to the supplier using blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection.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 reports: 0001032347-2017-00834-2.

• 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: 7082601
• MDR Text Key: 94806006
• Report Number: 0001032347-2017-00833
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 555900
• Other Device ID Number: (01)00841036123130(10)555900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1