MAUDE Adverse Event Report: CONMED LINVATEC RASP LIBERATOR KNIFE II, 4.75 X 149MM

Catalog Number 25-50016

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The involved rasp liberator knife ii is expected but has not yet been received for an evaluation.A follow-up submission will be filed once the device has been received and the evaluation has been completed.

Event Description

The user facility reported that the rasp liberator knife ii blade broke during use in a shoulder superior labrum anterior to posterior (slap) repair.The broken portion was retrieved from the shoulder which contributed to a 20-minute delay.As reported, no patient injury occurred and the procedure was completed as intended.There has been no additional information received regarding the patient's latest condition or any indication that a long term adverse effect has occurred.

Manufacturer Narrative

The involved rasp liberator knife ii was received for an evaluation on 06-jan-2015.A visual inspection of the returned device verified that the breakage occurred at the tip of the blade.A metallurgist studied the break and noted that the material is strong but brittle.There is no evidence of porosity.It does not appear that the break is related to the material or manufacturing process.The break appears to be the result of misuse of the device.Lot# 250956 was manufactured on 10-mar-2011.This is a reusable manual instrument over 4.5 years old that is cleaned and sterilized between uses.A two year review of complaint history shows no similar reports for this product.This failure mode is addressed in the fmea, and the safety risk has been found to be acceptable.The ifu provides the following cautions: inspect instruments prior to use to ensure proper function; no loose pins or misalignment, and that the instrument is in good physical condition.Inspect instruments after use to ensure it has not been damaged.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.

• Brand Name: RASP LIBERATOR KNIFE II, 4.75 X 149MM
• Type of Device: RASP
• Manufacturer (Section D): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer (Section G): CONMED LINVATEC; 11311 concept blvd.; largo FL 33773
• Manufacturer Contact: brenda johnson ; 11311 concept blvd.; largo, FL 33773 ; 7273995515
• MDR Report Key: 5265108
• MDR Text Key: 32667032
• Report Number: 1017294-2015-00077
• Device Sequence Number: 1
• Product Code: HTS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25-50016
• Device Lot Number: 250956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Weight: 85