MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMP 10MM HUM FRACT TRIAL; TEMPLATE FOR CLINICAL USE

Model Number N/A

Device Problem Entrapment of Device (1212)

Patient Problem Tissue Damage (2104)

Event Date 06/27/2016

Event Type  Injury  

Manufacturer Narrative

The following sections could not be completed with the limited information provided.Lot number.Requested but not returned by hospital.

Event Description

During a total shoulder arthroplasty the surgeon trialed the trial humeral stem too far into the humerus.Upon removal, the trial became lodged and the surgeon made a small osteotomy to remove it and then secured it with cables.

• Brand Name: COMP 10MM HUM FRACT TRIAL
• Type of Device: TEMPLATE FOR CLINICAL USE
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5831072
• MDR Text Key: 50713798
• Report Number: 0001825034-2016-02803
• Device Sequence Number: 1
• Product Code: HWT
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2016

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?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-406910
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention