MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE HUMERAL HEAD EXTRACTOR; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-9401-17

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device met all material specifications as received.The evaluation revealed a broken distal tip on the returned device.Device history record review revealed nothing relevant to this event.The complainant's event is typically caused by user mechanical damage from dropping the device or hitting the device against another device.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.

Event Description

It was reported that while trying to remove the implant and working with it underneath, the tip of the eclipse humeral head extractor broke-off in the patient.Surgeon was not able to retrieve the broken tip.The case was completed successfully.Additional information received 5/11/17: procedure was an apex primary tsa.Surgeon was trying to rotate the offset on the humeral head implant.Surgeon felt it was off by about 10 degrees and was trying to adjust it.A small fragment of metal, the broken-off tip of the device, was left in the patient engaged in the morse tape of the trunnion and humeral head implants.The fragment was reported to be contained and not floating in the patient.

• Brand Name: ECLIPSE HUMERAL HEAD EXTRACTOR
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6581008
• MDR Text Key: 75602037
• Report Number: 1220246-2017-00178
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867060333
• UDI-Public: 00888867060333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 05/22/2017

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: Health Professional
• Device Catalogue Number: AR-9401-17
• Device Lot Number: 250160104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2017
• Initial Date FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other