MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.5MM DRILL W/AO QC LONG; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	71175022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a big tibial plateau surgery, the evos small 2.5mm drill w/ao qc long broke, internal to patient.The procedure was finished using a smith and nephew back up device, with a surgical delay of less than 30 minutes.The patient was not injured beyond the described event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the breakage was confirmed.The clinical / medical investigation concluded that, the fluoroscopic image provided confirmed the reported broken drill bit and that it was extruding beyond the bone on the opposite side.Based on the limited information provided the root cause of the reported breakage cannot be determined.The material composition of the possible retained drill is comprised of martensitic stainless steel, 440a, which is noted in the astm f 988-2002 as an alloy that is utilized in medical devices.The 440a drills are manufactured and intended as externally communicating devices and are not approved for implantation.Therefore, long term implantation data is not available.If retained, the impact to the patient beyond the likely irritation and/or discomfort, micromotion/or migration, and additional radiological imaging/exposure cannot determined.No further medical assessment can be rendered at this time.A review of the complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from misuse or rough handling are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: EVOS SMALL 2.5MM DRILL W/AO QC LONG
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10453548
• Report Number: 1020279-2020-04217
• Device Sequence Number: 19801494
• Product Code: HWE
• UDI-Device Identifier: 00885556635766
• UDI-Public: 00885556635766
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71175022
• Device Catalogue Number: 71175022
• Device Lot Number: 20BUQ0027
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention