MAUDE Adverse Event Report: BIOMET ORTHOPEDICS VERSO FORKED RETRACTOR/UK; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/02/2012

Event Type  Injury  

Event Description

It was reported patient underwent a reverse total shoulder arthroplasty on (b)(6) 2012.During the procedure, one of the retractor prongs fractured while inserting the locking screws.Subsequently, the fractured fragment was unable to be removed and remains in the patient.

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 related to the event.There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling.Care must be taken to avoid compromising their exacting performance." 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.

Manufacturer Narrative

The returned retractor was evaluated and was found to have been manufactured within specifications.Visual examination of the retractor revealed signs of wear.In addition, artifacts at the fracture suggest a possible bending overload failure originating along the medial edge.

• Brand Name: VERSO FORKED RETRACTOR/UK
• Type of Device: PROSTHESIS, SHOULDER
• 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: 4233258
• MDR Text Key: 5001869
• Report Number: 0001825034-2014-08530
• Device Sequence Number: 1
• Product Code: GAD
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2015

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: 402852
• Device Lot Number: 111970
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 11/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2010
• 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
• Patient Age: 80 YR