MAUDE Adverse Event Report: BIOMET MICROFIXATION HTR-PMI; HARD TISSUE REPLACEMENT

Model Number N/A

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

A surgical delay greater than 30 minutes was reported due to the implant being too small for the patient's defect.

Manufacturer Narrative

The implant is designed to match the patient defect at the time of the ct scan.The instructions for use (ifu) indicates that possible modifications may be needed for the implant to fix as intended at the time of surgery.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.

• Brand Name: HTR-PMI
• Type of Device: HARD TISSUE REPLACEMENT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: amanda sisk ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 3840235
• MDR Text Key: 20784342
• Report Number: 0001032347-2014-00175
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK924935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: N/A
• Device Catalogue Number: PM614218
• Device Lot Number: 482930
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization