MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER 4.0 EP-1 DSPL BL; SAW, POWERED, AND ACCESSORIES

Catalog Number	7205326
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, the sealed packaging of the acromionizer blade was damaged and deformed, and the sterile barrier was compromised.There was a back-up device available, and no delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation showed one box (six blades) was returned in original packaging with the batch number of the complaint on the label.The color scheme of the device matches the print.The box has been opened, torn, and taped on both ends.The individual trays are unopened.They have been exposed to extreme heat which has deformed the plastic and stressed the seals.No other visible defect.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.A review of the form, fill and seal packaging sequence for found that the vision system (product inspection) will perform 100% visual inspection on each cycle (6 trays) for the following attributes: inner assembly (sluff chamber), outer assembly (adaptor body), petg insert.The root cause was associated with transport/storage.Factors that could have contributed to the reported event include rough handling during transport or storage, or exposure of the packaging to excessive heat.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: ACROMIONIZER 4.0 EP-1 DSPL BL
• 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: 21318323
• Report Number: 1219602-2025-00282
• Device Sequence Number: 8696387
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: 3596010251541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (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
• Report Date (Section B): 03/10/2025

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: 7205326
• Device Lot Number: 51029046
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2022
• 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