MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5 MM LACTOSORB ADJUSTABLE SELF-DRILLING TAP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 01/06/2016

Event Type  Injury  

Manufacturer Narrative

Review of material certifications show that the tap was released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.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.This is report three (3) of six (6) for the same event.Report 1 of 6 is reported on mfr #0001032347-2016-00180; report 2 of 6 is reported on mfr #0001032347-2016-00181; report 4 of 6 is reported on mfr #0001032347-2016-00183; report 5 of 6 is reported on mfr # 0001032347-2016-00186; and report 6 of 6 is reported on mfr # 0001032347-2016-00187.

Event Description

It was reported that screws broke during surgery.Additionally, the distributor reported a plate was slightly "afloat" on the patient's bone.Events resulted in a one-hour surgical delay.

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.This is report 2 of 3 for the same event.Reports 1 & 3 are reported on mfr #0001032347-2016-00180-1 & 0001032347-2016-00181-1.

Manufacturer Narrative

Please disregard mfr #0001032347-2016-00182-1 as this product was not returned for evaluation.

• Brand Name: 1.5 MM LACTOSORB ADJUSTABLE SELF-DRILLING TAP
• Type of Device: TAP
• 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: 5600298
• MDR Text Key: 43434088
• Report Number: 0001032347-2016-00182
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 915-1595
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2013
• 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): Hospitalization