MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL MICRORAPTOR HARD BONE 1.8MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72205267
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a dislocation surgery a drill microraptor hard bone was used, while drilling the device generated metal powder, part of the material was removed with suction, but the metal powder could not be completely removed from the patient.The procedure was successfully completed.A delay of 10 minutes was reported.A competitor device was used.No further complications were reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no way to determine if the device contributed to the reported event.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was 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 risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.According to the report, some of the powder remained inside of the patient.The drill is comprised of medical grade abs, lustran 348, pre-colored or color concentrate, clariant sb02664911 (white), which is not intended for implantation.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration of the possible retained metal powder cannot be determined.Since there were no other complications reported, no further clinical/medical assessment is warranted at this time.The complaint was not confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.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.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.H11: this report was inadvertently submitted under manufacturer number ¿1643264¿, the correct manufacturer number is ¿1219602.¿.

• Brand Name: DRILL MICRORAPTOR HARD BONE 1.8MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12952124
• Report Number: 1643264-2021-02458
• Device Sequence Number: 20034618
• Product Code: MAI
• UDI-Device Identifier: 00885556736234
• UDI-Public: 00885556736234
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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 Expiration Date: 08/29/2024
• Device Model Number: 72205267
• Device Catalogue Number: 72205267
• Device Lot Number: 50825387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 10 YR
• Patient Sex: Male