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	03/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during set up it was found that the inner packaging of the acromionizer was damaged and could not be used.There was a back-up device available and a surgical delay less than 30 minutes was reported.There was no patient involvement.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original unopened packaging, the packaging has been damaged , the capsule over the blade is dented and the corner near the hub is completely fractured, releasing the seal.A review of the customer supplied image finds the complaint device, without the protective outer cardboard box, badly damaged.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 insert, blister tray, ffs blades found that parts must be free of blowouts and burn marks, incomplete forming, smudges, grease and oil spots, nicks, burrs spikes or ragged edges, cuts, tears or cracks.The root cause was associated with transport or storage.Factors that could have contributed to the reported event include exposure to excessive heat and/or inappropriate storage conditions.No containment or corrective actions are recommended at this time.

• 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: 19140344
• Report Number: 1219602-2024-00833
• Device Sequence Number: 17993595
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: 03596010251541
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/07/2024

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: 7205326
• Device Lot Number: 50977425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2021
• 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