MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHOULDER SUSPENSION KIT LATEX FREE; ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Catalog Number	72200195
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	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, the shoulder suspension kit had a packing issue; there was a little hole in the sterile wrapping paper.The procedure was completed using the same device.There was a surgical delay less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10 h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.A review of the device drawings found that a certificate of compliance and certificate of sterility are required, and the sterilization processing records are to accompany the product.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.A review of the device drawings found that a certificate of compliance and certificate of sterility are required, and the sterilization processing records are to accompany the product.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.

• Brand Name: SHOULDER SUSPENSION KIT LATEX FREE
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 19538246
• Report Number: 3003604053-2024-00023
• Device Sequence Number: 8412505
• Product Code: FWZ
• UDI-Device Identifier: 03596010554017
• UDI-Public: 03596010554017
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/13/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 72200195
• Device Lot Number: 032123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 06/19/2024; 09/20/2024; 11/12/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 06/21/2024; 09/24/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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