MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLUTED 2.6MM FOR 2.3MM ANCH; BIT, DRILL

Model Number	72201824
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a surgery the drill bit broke in the patient while drilling.It is unknown if there was an available back up device or a significant delay during the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A clinical investigation concluded no relevant clinical information was provided to perform a thorough investigation.Per report, all of the pieces were retrieved with graspers.It is unknown if there was an available backup device or a significant delay during the procedure.Since there were no other complications reported and the patient condition has been reported as healthy, no further assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.Internal complaint reference: (b)(4).

• Brand Name: DRILL FLUTED 2.6MM FOR 2.3MM ANCH
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10597200
• Report Number: 1219602-2020-01484
• Device Sequence Number: 19790932
• Product Code: HTW
• UDI-Device Identifier: 03596010648068
• UDI-Public: 03596010648068
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 72201824
• Device Catalogue Number: 72201824
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 05/24/2021
• 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