MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL FLEXIBLE CANNULATED 9.5MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number	72203165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the cannulated flexible drill felt used and did not have the length mark numbers any longer; the drill broke.The procedure was completed using a s+n back up device.There was no surgical delay.No further complications were reported.
Event or Problem Description
It was reported that during an arthroscopy, the cannulated flexible drill felt used and did not have the length mark numbers any longer; the drill broke inside the patient, all the pieces were removed with a passing pin and pituitary.The procedure was completed using a s+n back up device.There was no surgical delay.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 device shows heavy wear from use, the laser etchings are barely legible.The distal end of the drill is fractured away and was not returned.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 no similar reported events.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.The root cause was associated with unintended use of the device.Factors, which could have contributed to the complaint event, include an application of excessive or repeated force over time resulting in wear from use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: DRILL FLEXIBLE CANNULATED 9.5MM
• 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: 19131510
• Report Number: 1219602-2024-00820
• Device Sequence Number: 15176381
• Product Code: NBH
• UDI-Device Identifier: 03596010654588
• UDI-Public: 03596010654588
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72203165
• Device Lot Number: 50834969
• 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: 03/24/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 05/14/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 05/03/2024; 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown