MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 2.0MM DRILL SHORT W/AO QC; BIT, DRILL

Model Number	71174910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, while the doctor was drilling with the 2.0 drill, the drill guide snapped off and was on the drill bit (no parts fell into the patient).This did not add any substantial time to the case because an s&n back up was available.There was no harm to the patient or staff.
Additional Manufacturer Narrative
The devices, used in treatment, were returned for evaluation.Part number 71174934: a visual inspection confirms the 2.0 drill guide came apart from the device and the 2.0mm drill w/ao qc is stuck in the drill guide (part number 71174910) all parts were returned for evaluation.The instruments were manufactured in 2014 and 2015.These devices exhibit signs of significant use and wear.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.These devices are reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: 2.0MM DRILL SHORT W/AO QC
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9429276
• Report Number: 1020279-2019-04316
• Device Sequence Number: 14013948
• Product Code: HTW
• UDI-Device Identifier: 00885556386798
• UDI-Public: 00885556386798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 71174910
• Device Catalogue Number: 71174910
• Device Lot Number: 15DNX0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR