MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL, FLEXIBLE,ENDOSCOPIC,CANN, 8MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	7209737
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill bit head broke off in the patient's femur during an acl.The femur was extremely hard bone in a young patient and broke off while backing the drill out of the femoral socket.The surgeon thought he was drilling out in forward.The drill bit head that broke off was a clean break/single piece that was retrieved out of the patient with 5 min delay.No patient injuries were reported.
Additional Manufacturer Narrative
One 8mm flexible endoscopic drill was returned for evaluation.Visual assessment of the drill confirmed the reported breakage.The entire drill head has broken off where it transitions to the double helix.There are no material voids at the break area.Examination of the drill heads primary cutting edge showed they are dull and damaged.The cannulation is heavily burred.

• Brand Name: DRILL, FLEXIBLE,ENDOSCOPIC,CANN, 8MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7754410
• Report Number: 1219602-2018-00992
• Device Sequence Number: 186481
• Product Code: HWE
• UDI-Device Identifier: 03596010541987
• UDI-Public: (01)03596010541987(10)50533950
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2018

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: 7209737
• Device Catalogue Number: 7209737
• Device Lot Number: 50533950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR