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

Catalog Number	71174911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke during the surgery, tip of broken drill fell into the patient's wound and was left in the patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.The clinical/medical team concluded, it was reported that a broken drill tip is retained in the patient.There are no radiographs or medical documents provided for review.The retained drill bit tip is comprised of 17-4 stainless steel material.Based on astm and iso standards, the drill bit material composition would fall into a standardized medical grade alloy and, although not approved for implantation, standardized alloys have not been determined to cause injury or harm when the duration of contact with tissues/blood/bone is short-term, however, the drill tip (fragment) is not intended as an implantable device.As the location of the fragment was not reported, the future impact to the patient cannot be determined, since it is unknown if micro-motion could occur.No further clinical assessment is warranted based on the limited details provided.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: 2.0MM DRILL LONG W/AO QC
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7720815
• Report Number: 1020279-2018-01403
• Device Sequence Number: 903863
• Product Code: MDM
• UDI-Device Identifier: 00885556386842
• UDI-Public: 00885556386842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71174911
• Device Lot Number: 15KNX0002A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 03/22/2019
• 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: Other