MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS DRAD 1.8MM DRILL AO QC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71158092
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the evos dvr system used drill that has laser lines on it.It was mentioned that these lines are very small and that synthes (competitor device) has a option for a depth gauge over the drill.It was mentioned that this would be specifically helpful to have as the laser lines are far to small to read off the drill bit.It is unknown if there was a delay in the case.No injury or intervention reported.It is unknown what procedure was being performed.
Additional Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: EVOS DRAD 1.8MM DRILL AO QC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10584880
• Report Number: 1020279-2020-04856
• Device Sequence Number: 14210132
• Product Code: LXH
• UDI-Device Identifier: 00885556692769
• UDI-Public: 00885556692769
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71158092
• Device Catalogue Number: 71158092
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/30/2020
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/01/2021
• 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