MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM CONTRA ANGLE CROSS-DRIVE BLADE; SCREWDRIVER

Model Number N/A

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(64.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00305, 0001032347-2020-00306.Concomitant of medical products: traumaone system contra angle cross-drive blade, part# sp-2379, lot# 859910.Traumaone system contra angle cross-drive blade, part# sp-2379, lot# 694020.Distributor on behalf of facility.The complaint is confirmed.A visual inspection was conducted and both t1 blade x-dr showed heavy signs of usage.Several attempts to pick-up/secure new screws (95-6104) with the blades failed.The contra angle t1 blade x-dr is worn and unable to function as intended.The dhr was reviewed for this product; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint in regards to the contra angle t1 blade x-dr not functioning for part sp-2379, lot 859910.For this part sp-2379 and the previous one year (from the notification date) regarding the instruments damage/wear, there is a complaint rate of 0.21%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the damaged is wear and tear from usage.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported two (2) blades were dull and would not retain screws during surgery.No adverse events have been reported as a result of the malfunction.

• Brand Name: TRAUMAONE SYSTEM CONTRA ANGLE CROSS-DRIVE BLADE
• 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: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10260609
• MDR Text Key: 199072713
• Report Number: 0001032347-2020-00305
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 00841036135379
• UDI-Public: 00841036135379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/10/2020

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: SP-2379
• Device Lot Number: 859910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 07/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• 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