MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM CANN DRILL BIT W/QC; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	71177110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, while drilling the bone, drill broke inside a tissue protector.No delay and no injury.Procedure was concluded with a backup device from smith and nephew.
Additional Manufacturer Narrative
The associated complaint device was not returned.Per photos attached, the device appears to have the tip broke off.The photos don't show the broken piece in the photos.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.No further actions are being taken at this time.

• Brand Name: 2.0MM CANN DRILL BIT W/QC
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8719958
• Report Number: 1020279-2019-02353
• Device Sequence Number: 19400114
• Product Code: MDM
• UDI-Device Identifier: 03596010624307
• UDI-Public: 03596010624307
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 71177110
• Device Lot Number: 13FHU0005
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1