MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.7MM SHORT DRILL {} BIT W/QC; PLATE, FIXATION, BONE

Model Number	71173502
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill snapped/broke while drilling through the implant.All pieces were recovered.There was an s&n backup device available.There were no delays in the procedure and no patient injuries were reported.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.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 prolonged use or misuse are likely probable causes of the reported event.We recommend that all instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 2.7MM SHORT DRILL {} BIT W/QC
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9662593
• Report Number: 1020279-2020-00461
• Device Sequence Number: 11547113
• Product Code: HRS
• UDI-Device Identifier: 03596010519702
• UDI-Public: 03596010519702
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123055
• 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): 05/06/2020

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: 71173502
• Device Catalogue Number: 71173502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1