MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS SMALL 2.5MM DRILL W/AO QC SHORT; INSTRU, SURGICAL, ORTHO, AC-POWER MOTOR AND ACCESSORY/ATTACHMENT

Model Number	71175023
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the drill bit jammed in the drill guide whilst sitting in a plate hole inside the patient.One part got stuck on the drill bit, the other was still in the surgeon¿s hand.All parts were retrieved from inside the patient.Less than 5 minutes delay was reported and a backup device was available.No harm to patient was recorded.
Additional Manufacturer Narrative
The devices, used in treatment were not returned for evaluation.A visual inspection of the photos attached to the complaint confirms the drill bit is stuck on one side of the drill guide.The side of the drill guide that the drill bit is stuck in has broken off the drill guide.These devices were manufactured in 2017 and 2019.These devices exhibit signs of significant wear and use.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: EVOS SMALL 2.5MM DRILL W/AO QC SHORT
• Common Device Name: INSTRU, SURGICAL, ORTHO, AC-POWER MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9729354
• Report Number: 1020279-2020-00638
• Device Sequence Number: 2179728
• Product Code: HWE
• UDI-Device Identifier: 00885556635773
• UDI-Public: 00885556635773
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/22/2020

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: 71175023
• Device Catalogue Number: 71175023
• Device Lot Number: 19EUQ0004C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71175041, EVOS 2.5MMX3.5MM DRILLGUIDE, 17MSC0019