MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCPC CANN 5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72202972
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl surgery, the flexible reamer broke inside the patient while reaming for the endobutton tunnel, all the broken pieces were removed using hemostat.The procedure was completed with a back up device with no delay or patient injury reported.
Additional Manufacturer Narrative
One 5mm flexible endoscopic cannulated drill bit was returned for evaluation.Visual assessment of the drill confirmed the reported complaint of breakage.The drill has broken where the lazer cut double helix transitions from the 20½ to 9 revolutions per inch.No material voids are present at the break areas.The drills shaft is bent.The primary cutting edges are dull and are heavily burred.Per the device instructions for use under precautions ¿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¿.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The reported 5mm flexible cannulated endoscopic drill intended for use in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the drill broke during use.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: use of excessive force or using a dull or worn drill.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: DRILL FLEXIBLE ENDOSCPC CANN 5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8962524
• Report Number: 1219602-2019-01092
• Device Sequence Number: 16858804
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: 03596010654533
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2019

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: 72202972
• Device Lot Number: 50517095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 10/02/2019; 10/30/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/03/2019; 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1