MAUDE Adverse Event Report: DRILL MICRORAPTOR HARD BONE 1.8MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72205267
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction to Medicinal Component of Device (4574)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that while in a clinical study using drill microraptor hard bone, the patient suffered a right hip locking.An mri was prescribed to the patient and the outcome of the patient is unknown at the moment.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that, while in a clinical study using a drill microraptor hard bone, the patient suffered a locked right hip 14 months after the procedure and required medication as treatment.An mri was prescribed to the patient.Patient's recovery is ongoing.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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 review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.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 review of risk management files found that the reported failure was documented appropriately.The patient impact beyond the reported event could not be determined based on the limited information provided.Since it was reported the patient's recovery is ongoing, no further clinical medical investigation is warranted at this time.Should any additional relevant medical information be provided, this complaint will be re-assessed.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.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.

• Brand Name: DRILL MICRORAPTOR HARD BONE 1.8MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• MDR Report Key: 10979674
• Report Number: 1219602-2020-02022
• Device Sequence Number: 14535497
• Product Code: MAI
• UDI-Device Identifier: 00885556736234
• UDI-Public: 00885556736234
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Model Number: 72205267
• Device Catalogue Number: 72205267
• Device Lot Number: 50804721
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/11/2020; 11/03/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 01/07/2021; 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2019
• 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: N
• Patient Sequence Number: 1