MAUDE Adverse Event Report: CONMED LARGO HALL PRIMECUT CASSETTE 1.27 X 105 X 20 MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number SH127-105-20

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that sh127-105-20, hall primecut cassette 1.27 x 105 x 20 m19 was being used on (b)(6) 2022 during a total knee replacement when it was reported ¿the saw blade broke while sawing under a total knee replacement.Metal chip came loose from the blade and ended up in the knee.The piece is re-fanned during the operation.¿ further assessment questioning found that the blade did fragment and the metal chip was removed from the patient's knee using a "pincett och peang" instrument.The procedure was completed with the use of another sh127-105-20 blade.There was also a 20-minute delay reported in the procedure.There was no report of injury, medical intervention or extended hospitalization required for the patient.The patient¿s current status is reported as ¿doing well and home from the hospital.¿ this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Event Description

The sales representative reported on behalf of the customer that sh127-105-20, hall primecut cassette 1.27 x 105 x 20 m19 was being used on (b)(6) 2022 during a total knee replacement when it was reported ¿the saw blade broke while sawing under a total knee replacement.Metal chip came loose from the blade and ended up in the knee.The piece is re-fanned during the operation.¿ further assessment questioning found that the blade did fragment and the metal chip was removed from the patient's knee using a "pincett och peang" instrument.The procedure was completed with the use of another sh127-105-20 blade.There was also a 20-minute delay reported in the procedure.There was no report of injury, medical intervention or extended hospitalization required for the patient.The patient¿s current status is reported as ¿doing well and home from the hospital.¿ this report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Correction: the initial report filed under 1017294-2022-00107 listed a health impact code 50675 in section f.10.This is incorrect and was selected as a typo.The correct codes for this final report are selected in h.6 manufacturer narrative: reported event, ¿broke,¿ is confirmed based on device evaluation.Evaluation of the returned used device, item sh127-105-20, found machined bur teeth damage, broken off.Returned product shows signs of misuse.Excessive force (load) was used during procedure.A two-year lot history review cannot be conducted as a lot number was not provided.A dhr review cannot not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 17 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 (b)(4).Per the instructions for use, the user is advised the following: do not use saw blades to pry, remove bone grafts, or as a leverage point.Do not apply excessive bending or twisting force to blade.Patient or user injury may occur.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.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HALL PRIMECUT CASSETTE 1.27 X 105 X 20 MM
• Type of Device: 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 15763092
• MDR Text Key: 307693558
• Report Number: 1017294-2022-00107
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: SH127-105-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic