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

Model Number N/A

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 10/09/2017

Event Type  Injury  

Manufacturer Narrative

A review of the device history records show the lot released with no recorded anomaly or deviation.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.This is report one of two for the same event.Report two of two is reported on mfr #0001032347-2017-00782.

Event Description

During a ribfix case, the surgeon attempted to use a contra angle temporary pin.However the pin became completely stuck in the driver after inserting into the patient's bone; the driver would not disengage despite multiple attempts.The pin remains stuck inside of the driver.The surgeon did not use another pin in the same hole; "he essentially had to rip the pin out of the bone." the event resulted in a delay of ten minutes due to having to reduce bone/ plate in a different way.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The product was returned in a biohazardous condition, therefore a visual inspection and an attempt at removal of the temporary fixation pin will occur through the bag.A visual inspection of the device through the bag confirms the complaint as there is a temporary fixation pin still within the drivers collet.The devices handle was turned to see if the driver would function.It was found that the driver still functioned when the handle was spun.The temporary fixation pin was attempted to be removed using a pair of pliers through the bag while sliding up the locking mechanism of the driver through the bag.It was found that the temporary fixation pin could not be removed.Root cause was unable to be determined due to the biohazardous state of the device.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.(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001032347-2017-00782-1.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.A correction was identified to the root cause statement submitted in report 0001032347-2017-00781-1, "root cause was unable to be determined due to the biohazardous state of the device." the correct statement is: investigation results concluded that the reported event 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.

• Brand Name: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Type of Device: RIGHT ANGLE SCREWDRIVER
• 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: 7003929
• MDR Text Key: 91131385
• Report Number: 0001032347-2017-00781
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 999220
• Other Device ID Number: (01)00841036123130(10)999220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention