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

Model Number	72204988
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during a an arthroscopy the drill of the microraptor was broken inside the body.All pieces were removed from the patient.The procedure was completed with a 45-minute surgical delay using a back up device.No further complications were reported.
Additional Manufacturer Narrative
Correction in b5.
Event or Problem Description
It was reported that during a an arthroscopy the drill of the microraptor was broken inside the body.The pieces were removed from the patient, but it was informed that there was a risk that some could be remained inside the patient.The procedure was completed with a 45-minute surgical delay using a back up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The distal 1/3 of the drilling surface is fractured away from the body and was returned in a baggie taped to the handle of the device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.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 risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states the drill bit is not intended for long term internal exposure and long-term implantation data is not available.The patient impact beyond the reported event cannot be determined; however, if any pieces remain there could be possible micro-motion and/or migration, and local irritation/discomfort.The root cause has been associated with unintended use of the device.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.No containment or corrective actions are recommended at this time.Corrected data: h6: health effect - clinical and impact code.

• Brand Name: MICRORAPTOR DRILL
• 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.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 16056687
• Report Number: 1219602-2022-02049
• Device Sequence Number: 4937150
• Product Code: MAI
• UDI-Device Identifier: 00885556710296
• UDI-Public: 00885556710296
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2023

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: 08/17/2026
• Device Model Number: 72204988
• Device Catalogue Number: 72204988
• Device Lot Number: 2070640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 12/21/2022; 10/30/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 12/27/2022; 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown