MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 4.0MM ELITE ACROMIONIZER BURR(6); SAW, POWERED, AND ACCESSORIES

Catalog Number	72200724
Medical Device Problem Codes	Material Deformation (2976); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a shoulder arthroscopy, five (5) dyonics acromionizer burrs were making a strange noise and the terminal fused.Surgery was completed after a significant delay (>30 min) using a back-up device instead.No further complications were reported.Patient's status is okay.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).D4, lot no.: the following are the lot numbers reported: 51093746 (2), 50982715 (1), and 51063053 (2).However, it is unknown which of the 5 devices contributed with the delay greater than 30 minutes.D4, exp.Date: expiration dates for each of the 3 lots reported: 31-dec-2027 (51093746), 07-dec-2026 (50982715), 04-sep-2027 (51063053).H4, mgf.Date: manufacturing dates for each of the 3 lots reported: 31-dec-2022 (51093746), 07-dec-2021 (50982715), 04-sep-2022 (51063053).
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4.Updated to initial use of device.The reported device was received for evaluation.A visual inspection of the returned devices found that they are not in their original packaging.Both devices were returned with biological debris on them, the inner and outer shafts are intact and the hubs have no heat damage.A functional assessment of the devices found they function as designed with a reference control unit with no unusual noises.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.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 could not be determined since the reported malfunction could not be duplicated during the investigation.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.

• Brand Name: DYONICS 4.0MM ELITE ACROMIONIZER BURR(6)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• 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: 17454747
• Report Number: 1219602-2023-01404
• Device Sequence Number: 7382695
• Product Code: HAB
• UDI-Device Identifier: 03596010578020
• UDI-Public: 03596010578020
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2023

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: 72200724
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 12/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2022
• 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
• Patient Sex: Unknown