MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCPC CANN 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number 72202971

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during a surgery, the drill flexible was removed and the bit was found to be broken on one side.The auger did not leave any scrap of metal inside the patient.It is unknown if there was an available back up device or a significant delay during the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

A 72202971 4.5mm flexible endoscopic cannulated drill used for treatment, was not returned for evaluation.This was a three year old reusable instrument.Instruction for use (ifu) 1061186 contains precautionary statements and recommendations for proper use of product.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.The flex drills are intended to flex but not be bent.Per ifu: ¿this is a limited reuse device based upon the sharpness of the drill tip.Use of drills with that have worn or dull tips can result in breakage.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure¿.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product or procedure failure that supported the allegation.Risk management files contain the reported failure.Product met specifications upon release to distribution.

• Brand Name: DRILL FLEXIBLE ENDOSCPC CANN 4.5MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10185911
• MDR Text Key: 196141805
• Report Number: 1219602-2020-00946
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: 03596010654526
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50693343
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 08/27/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention