MAUDE Adverse Event Report: BIOMET SET COMP CNV GLEN LINER IMPACTOR; PROSTHESIS, SHOULDER

Model Number N/A

Device Problems Component Falling (1105); Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 09/08/2015

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.There are warnings in the package insert that state that this type of event can occur: under precautions, it states, ¿intraoperative fracture or breaking of instruments has been reported for general instruments.¿.

Event Description

It was reported that patient underwent a total shoulder arthroplasty on (b)(6) 2015.During the procedure, the glenoid poly impactor fractured while inserting the poly.A piece fell into the patient and was retrieved.Another poly impactor was used to complete the procedure.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Product left conforming to print as there was no evidence that states otherwise.Visual review shows the side of the impactor head fractured and fractured off.Instrument fracture most likely occurred due to incorrect alignment.Based on these results the complaint is considered confirmed.

• Brand Name: COMP CNV GLEN LINER IMPACTOR
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): BIOMET SET; 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: 5136672
• MDR Text Key: 27815445
• Report Number: 0001825034-2015-04229
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK130390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• 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: 110005294
• Device Lot Number: 632310
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• Is the Device Single Use?: Yes
• 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): Required Intervention