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

Model Number	72202972
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that at the moment of staring the femoral tunnel, the drill bit was broken and the piece was removed with a clamp.No patient injury reported.
Additional Manufacturer Narrative
One 5mm flexible endoscopic drill was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.Drill has broken where the double helix transitions to 9 revs per inch.No material voids are present at the break area.Further examination of the drill head showed the primary cutting surface and flutes are damaged.The condition of the device indicates the drill was subjected to excessive forces during use.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.Further investigation is not warranted at this time.

• 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: 7034852
• Report Number: 1219602-2017-01419
• Device Sequence Number: 13687837
• Product Code: NBH
• UDI-Device Identifier: 03596010654533
• UDI-Public: (01)03596010654533(10)50597762
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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 Model Number: 72202972
• Device Catalogue Number: 72202972
• Device Lot Number: 50597762
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 23