MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE ENDOSCPC CANN 4.5MM; ACCESSORIES,ARTHROSCOPIC

Model Number	72202971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during arthroscopy procedure, inside the patient, using drill flexible endoscopic cann 4.5mm at the time of making the femur tunnel, the doctor pressed the reverse drill button and the drill broke inside the patient.A piece in the joint, wasn't removed.The procedure was finished with a smith and nephew backup device.No surgical delay.Patient injuries were not reported.
Additional Manufacturer Narrative
H10 h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A complaint history review found similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The markings on the device confirm the product identification information.The device is worn from use, and it fractured into multiple pieces.There is debris on the device.A review of the customer provided images found one image of the device fractured into multiple pieces.An x-ray image found a foreign material in the joint.Although requested, no supporting clinical information has been provided to assist with a clinical investigation.The drill is composed of 465 sst and intended as an externally communicating device, not approved for implantation; therefore, long-term implantation data is not available.The patient impact beyond possible corrosion, local irritation/discomfort, and/or migration cannot be determined.No further medical assessment can be rendered at this time.The complaint was confirmed and the root cause was 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.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 FLEXIBLE ENDOSCPC CANN 4.5MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• 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: 12523105
• Report Number: 1219602-2021-02122
• Device Sequence Number: 4231531
• Product Code: NBH
• UDI-Device Identifier: 03596010654526
• UDI-Public: 03596010654526
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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 Model Number: 72202971
• Device Catalogue Number: 72202971
• Device Lot Number: 50806552
• 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: 09/04/2021
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown