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 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records show that the lot was 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.

Event Description

It was reported a contra angle driver that did not function during a procedure.It was reported the driver appeared to be stripped.It was reported the surgeon used the available spare driver.It was reported there was a two minute delay to exchange the drivers.

Manufacturer Narrative

The product was returned for evaluation.The product identity was confirmed in the evaluation.The driver was visually evaluated and shows signs of normal use.The driver was tested and found to function as intended with no issues.Therefore, the complaint is unconfirmed.The most-likely cause of the complaint could not be determined as no issue was found.According to the evaluation, there are no indications for manufacturing defects.

Manufacturer Narrative

This report was submitted to correct the device product code and 510(k) number.The following sections were corrected: device product code: jey corrected to hrs.Pma/510(k) number: k121589 corrected to k142823.(b)(4).

Event Description

This follow-up report is being submitted to relay corrected and additional information.

• 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: 6138195
• MDR Text Key: 61236223
• Report Number: 0001032347-2016-00726
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142823
• 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,Followup
• Report Date: 12/11/2018

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 465660
• Other Device ID Number: (01)00841036123130(10)465660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; 11/29/2018
• Supplement Dates FDA Received: 01/30/2017; 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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