MAUDE Adverse Event Report: CONMED CORPORATION MENISCAL RASP, 30 DEGREE, BOTTOM AND TOP SERRATIONS; ACCESSORIES, ARTHROSCOPIC

Catalog Number C8537.1

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

Patient code was not available, an additional, unplanned incision was made to retrieve device fragment.Customer complaint that "the rasp broke off and a piece floated to back of the knee but was retrieved" is inconclusive.The alleged broken c8537.1, meniscal rasp, is not expected to be returned to conmed for evaluation.Should the device be returned an evaluation will be performed.Upon completion of the complaint investigation a supplemental and final report will be filed.Otherwise, this filing will stand as the final report.The manufacturing documents from the device history record could not be conducted due to the unavailability of the lot number.A two-year lot history could not be conducted due to the unavailability of the lot number.A two-year review of complaint history revealed there has been 2 complaints regarding 2 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4) per the instructions for use, the user is advised the following; 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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

It was reported via medwatch# mw5085673, that the c8537.1, meniscal rasp, broke while debriding cartilage during a knee arthroscopy on (b)(6) 2019.The piece floated to the back of the knee requiring the surgeon to have to create an additional incision in the back of the knee to be able to insert a posteriomedial portal.The fragment was retrieved successfully.Further attempts to gather information were made, but no additional information was provided.This report is being raised due to patient requiring additional surgical intervention.

• Brand Name: MENISCAL RASP, 30 DEGREE, BOTTOM AND TOP SERRATIONS
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer (Section G): CONMED CORPORATION; 11311 concept boulevard; largo FL 33773
• Manufacturer Contact: melanie hansen ; 11311 concept boulevard; largo, FL 33773 ; 7273995209
• MDR Report Key: 8612023
• MDR Text Key: 145125231
• Report Number: 1017294-2019-00055
• Device Sequence Number: 1
• Product Code: NBH
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C8537.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/15/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other