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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product-contra angle temporary fixation screw catalog #: 76-0017, lot: ni, therapy date: (b)(6) 2017.The 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: 0001032347-2017-00838.

Event Description

It was reported three contra angle drivers stripped during surgery.During a rib fixation procedure the temporary fixation screw stuck in the driver and surgeon was not able to remove it.The issue was resolved by backing the post out and using a new driver.There was a five minute delay and no injury to the patient.

Manufacturer Narrative

Concomitant medical product: 90 degree contra angle screwdriver, catalog #: 24-1189, lot: ni.A total of three drivers was reported, however only one driver was returned and the lot number identified.Report 0001032347-2018-00014 was submitted for the two drivers that have not been returned and the lots remain unknown.The fixation pin (catalog # 76-0017) reported in 0001032347-2017-00838 was also not returned.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.A visual inspection was conducted of the returned driver and it was observed that there was no temporary fixation pin stuck within the driver.Also there was no returned temporary fixation pin.A contra angle driver blade was inserted into the driver and it was found that the blade could lock into the driver.The driver handle was spun and the blade turned in the collet.There are no indications of a manufacturing defect.Device history record (dhr) was reviewed and no discrepancies were found.The complaint was not confirmed.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: 0001032347-2017-00838-1 and 0001032347-2018-00014-1.

• Brand Name: 90 DEGREE CONTRA ANGLE SCREWDRIVER
• Type of Device: 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: 7079486
• MDR Text Key: 94793324
• Report Number: 0001032347-2017-00837
• 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: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• 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: 555890
• Other Device ID Number: (01)00841036123130(10)555890
• 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: 04/15/2018
• 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