MAUDE Adverse Event Report: BIOMET MICROFIXATION ROOT TEASER #3652

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It is noted that the customer shows possible lots of 040815c15 and 041013d13 for this item.However, the lot number could not be confirmed at this time.Because the lot number is unknown, the device history records could not be pulled and reviewed.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 four of four for the same event.Reports one through three are reported on mfr #0001032347-2016-00605 through 0001032347-2016-00607.

Event Description

It is reported that this instrument's tip broke during a procedure.It is reported that all parts were retrieved and there was no foreign body in the patient.It is reported that the event did not lead to a delay of more than thirty minutes.

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 four of four for the same event.Reports one through three are reported on mfr #0001032347-2016-00605 through 0001032347-2016-00607.

Manufacturer Narrative

The product was returned for evaluation.The product identity was confirmed and the lot was identified in the evaluation.A visual inspection revealed moderate signs of wear including minor scratches and spots of discoloration.This product was found to have a broken tip; therefore the complaint is confirmed.The most likely underlying cause was determined to be excessive applied force.According to the evaluation, there are no indications of manufacturing defects.This is report four of nine for the same event.Reports one through three and five through nine are reported on mfr #0001032347-2016-00605-2 through 0001032347-2016-00607-2 and 0001032347-2016-00770 through 0001032347-2016-00774.

• Brand Name: ROOT TEASER #3652
• Type of Device: TEASER
• 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: 6051845
• MDR Text Key: 58204904
• Report Number: 0001032347-2016-00608
• Device Sequence Number: 1
• Product Code: EMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

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: 09-0202
• Device Lot Number: 041013D13
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2016; 12/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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
• Patient Outcome(s): Required Intervention