MAUDE Adverse Event Report: CONMED LARGO PRESSFT DRILL BIT 2.1MM, HIP; BIT, SURGICAL

Catalog Number TD21H

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2023

Event Type  Injury  

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.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text: device not yet received.

Event Description

International complaints reported on behalf of the customer that the td21h, pressft drill bit 2.1mm, hip device was being used during a hip arthroscopy procedure on 16may23 when it was reported ¿the third use of the drill for the insertion of acetabular implants occurred the rupture.The piece is totally inside the bone without surfacing.¿.It was also reported that ¿the broken drill bit remained in the patient and was not removed.¿.There was no report of surgical intervention or extended hospitalization required for the patient.This report is being raised on the reported injury due to foreign body left inside the patient.

Manufacturer Narrative

Reported event of ¿the piece is totally inside the bone without surfacing.¿ is confirmed.Examination of the returned used item found the drill bit broken off at the shaft etch line.The broken piece was not returned for the evaluation.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.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 1 complaint, regarding 1 device, 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 that prior to use, cleaning or sterilization, remove all protective packaging and tip protector, if applicable.Inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

International complaints reported on behalf of the customer that the td21h, pressft drill bit 2.1mm, hip device was being used during a hip arthroscopy procedure on (b)(6) 2023 when it was reported ¿the third use of the drill for the insertion of acetabular implants occurred the rupture.The piece is totally inside the bone without surfacing.¿.It was also reported that ¿the broken drill bit remained in the patient and was not removed.¿.There was no report of surgical intervention or extended hospitalization required for the patient.This report is being raised on the reported injury due to foreign body left inside the patient.

• Brand Name: PRESSFT DRILL BIT 2.1MM, HIP
• Type of Device: BIT, 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: 17010300
• MDR Text Key: 316017636
• Report Number: 1017294-2023-00049
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 10845854901908
• UDI-Public: (01)10845854901908(11)191010(10)1053941
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: TD21H
• Device Lot Number: 1053941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic