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

Catalog Number	72202972
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when passing the flexible drill bit, the drill bit broke inside the patient.No significant delay was reported.Is unknown if a backup device was available.No patient injuries were 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 entire drill head has broken off the drill shaft and was not returned for evaluation.The drill has broken in two locations: at the drill head tip pulse marks, and 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.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: the application of excessive force.Using a drill that is worn or has dull tips.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.
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.
Event or Problem Description
It was reported that when passing the flexible drill bit, it broke inside the patient.No significant delay was reported.Is unknown if a backup device was available.The pieces were removed from the patient and there were no injuries reported.

• 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: 8640366
• Report Number: 1219602-2019-00600
• Device Sequence Number: 19293925
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: 03596010654533
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2019

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: 50559238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/08/2019; 10/18/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/09/2019; 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR