MAUDE Adverse Event Report: CONMED LARGO HALL®; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	00507126700
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the 00507126700, oscillator blade, coated, 19.5 x 95 x 1.27 mm, 5pk was being used during a total hip arthroplasty and ¿the tooth of an oscillating blade broke off and fell into the patient during a tha.Delay of 40 minutes.¿.There was no impact or injury for the patient or user.The procedure was completed with a ¿different blade¿.The tooth was retrieved from the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
Additional Manufacturer Narrative
Examination of returned used product found the blade damage with a tooth broken off.The broken tooth was not returned for evaluation.Examination performed per 00507126700.The likely cause for this event is due to the application of excessive force and/ or collision with another instrument during use.A 2 year lot history review shows a total of 2 devices for this lot number and failure mode.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.(b)(4).Per the instructions for use, the user is advised the following: always inspect for bent, dull or damaged blades or burs before each use.Do not attempt to straighten or sharpen.Do not use if damaged.The user is also advised to avoid contact of blades and burs with cutting blocks, retractors or other instrumentation.Damage to the blade, bur or instrument may occur.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 00507126700, oscillator blade, coated, 19.5 x 95 x 1.27 mm, 5pk was being used during a total hip arthroplasty and ¿the tooth of an oscillating blade broke off and fell into the patient during a tha.Delay of 40 minutes.¿ there was no impact or injury for the patient or user.The procedure was completed with a ¿different blade¿.The tooth was retrieved from the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: HALL®
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19850805
• Report Number: 1017294-2024-00090
• Device Sequence Number: 17744648
• Product Code: GFA
• UDI-Device Identifier: 20845854045968
• UDI-Public: (01)20845854045968(17)290401(10)1379502
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00507126700
• Device Lot Number: 1379502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic