MAUDE Adverse Event Report: BIOMET MICROFIXATION STP 1.5 C-DRIVE BLADE

Model Number N/A

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

The sales associate reported trauma one blades and a iq driver that is not functioning as intended during a trauma (t1 set) procedure.The driver was reported as being faulty and the blades will not pick up screws.The surgeon was able to successfully complete the procedure with a manual driver.

Manufacturer Narrative

The product was returned for an evaluation.The product identity was confirmed in the evaluation.The product was visually evaluated.In the visual evaluation, the blades appeared to be in good condition with minor scuffs near the base where it interacts with the driver handle and near the tip where it engages the screw.Both blades were functionally tested and functioned as intended; therefore the complaint is not confirmed.The most-likely cause was determined to be customer preference.The device history records were reviewed in the evaluation and no non-conformances were found.According to the evaluation, there are no indications of manufacturing defects.

• Brand Name: STP 1.5 C-DRIVE BLADE
• Type of Device: BLADE
• 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: 5937285
• MDR Text Key: 54279631
• Report Number: 0001032347-2016-00494
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

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: 01-7176
• Device Lot Number: 446700
• Other Device ID Number: (01)00841034013332(10)446700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2015
• 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