MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5X4MM HT SD X-DR SCREW EA; DRILLING SCREW

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 08/12/2016

Event Type  Injury  

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 the screw was not retained by the shaft of a driver during a procedure.No further information is available.

Manufacturer Narrative

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.

Manufacturer Narrative

The product was returned for evaluation.The product identity was confirmed in the evaluation.The product was visually evaluated with a digital microscope.The tip and side views of the visual inspection revealed sharp tip and threads.The top view of the visual inspection revealed damage across the threads indicating the product had been stripped.The product was functionally tested.The blade was unable to retain the product because of the damage to the product's head; therefore the complaint is confirmed.The most-likely cause was determined to be excessive force on the product's head.Because the lot number is unknown, the device history records could not be pulled and reviewed.

• Brand Name: 1.5X4MM HT SD X-DR SCREW EA
• Type of Device: DRILLING SCREW
• 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: 5950908
• MDR Text Key: 54749657
• Report Number: 0001032347-2016-00511
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 91-6104
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/14/2016; 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention