MAUDE Adverse Event Report: CONMED LARGO HALL 50; SAW, POWERED, AND ACCESSORIES

Catalog Number	PRO7400B
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the pro7400b, hall 50 reciprocating saw battery handpiece device was used in a total hip procedure on an unknown date and ¿the saw blade detached from the handpiece two times during one surgery.The nurse carefully attached the saw blade after the first time but it detached again during action despite that.The handpiece will be sent for repair.No harm came to the patient and they finished the surgery with another handpiece.".The procedure was completed with ¿another pro7400b¿ and a delay of 5 minutes.Further assessment found "the blade came loose during the cut of collum femoris.There were no patient impact or injury.There was a minimal delay in the surgery when they opened a new handpiece.The technicians in the hospital have investigated the handpiece and can¿t find anything wrong with it.They have decided to try the saw again during surgery and not returning it to us if does not happen again.The blade detached ¿ they had to stop and attach the blade again.The same thing happened again when they tried to complete the cut.They then brought in a different saw and completed the operation without complications.The blade was in the patient when they sawed.It came loose during the sawing itself.It didn't fall anywhere else.¿.There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The 00505229100, large bone hall blade, reciprocator, 12.5 x 76 x 1.27 mm will be listed as a concomitant device; there are no allegations against it.
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.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.The service history was reviewed, and no data was found.A two-year review of complaint history revealed there has been a total of three reports, regarding three devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.001.Per the instructions for use, the user is advised that it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories.Handle all equipment carefully.If any equipment is dropped or damaged in any way, return it immediately for service.Prior to each use, perform the following: ensure all accessories are correctly and completely attached.Perform the required preoperative functional tests for the equipment and accessories.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the pro7400b, hall 50 reciprocating saw battery handpiece device was used in a total hip procedure on an unknown date and ¿the saw blade detached from the handpiece two times during one surgery.The nurse carefully attached the saw blade after the first time but it detached again during action despite that.The handpiece will be sent for repair.No harm came to the patient and they finished the surgery with another handpiece.".The procedure was completed with ¿another pro7400b¿ and a delay of 5 minutes.Further assessment found "the blade came loose during the cut of collum femoris.There were no patient impact or injury.There was a minimal delay in the surgery when they opened a new handpiece.The technicians in the hospital have investigated the handpiece and can¿t find anything wrong with it.They have decided to try the saw again during surgery and not returning it to us if does not happen again.The blade detached ¿ they had to stop and attach the blade again.The same thing happened again when they tried to complete the cut.They then brought in a different saw and completed the operation without complications.The blade was in the patient when they sawed.It came loose during the sawing itself.It didn't fall anywhere else.¿.There was no report of medical/surgical intervention, or extended hospitalization for the patient.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.The 00505229100, large bone hall blade, reciprocator, 12.5 x 76 x 1.27 mm will be listed as a concomitant device; there are no allegations against it.

• Brand Name: HALL 50
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer (Section G): CONMED LARGO; 11311 concept blvd; largo FL 33773
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 21889937
• Report Number: 1017294-2025-00041
• Device Sequence Number: 8097597
• Product Code: HAB
• UDI-Device Identifier: 10845854040058
• UDI-Public: (01)10845854040058(11)220222
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: PRO7400B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 00505229100, LARGE BONE HALL BLADE; 00505229100, LARGE BONE HALL BLADE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic