MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT STABILIZATION SHOULDER (12); ACCESSORIES, OPERATING-ROOM, TABLE (KIT)

Model Number	7210573
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an unknown procedure, the staff found that the cuff was mixed with a hair when the package was opened.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection found shoulder kit from lot 20200910 was received out of packaging.There was a hair on the cuff, the customer had place tape over it to secure it.A review the customer provided image showed the kit out of package with a hair on the hair on the cuff.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.It was determined this was a isolated issue.A review of the material specifications found the assembly is visual inspected to ensure acceptable quality.The complaint was confirmed, but the root cause could not be determined with certainty.Factors that could have contributed to the reported event include the contact with foreign objects during manufacturing, packaging or once opened.No containment or corrective actions are recommended at this time.

• Brand Name: KIT STABILIZATION SHOULDER (12)
• Common Device Name: ACCESSORIES, OPERATING-ROOM, TABLE (KIT)
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11440189
• Report Number: 3003604053-2021-00070
• Device Sequence Number: 14292638
• Product Code: FWZ
• UDI-Device Identifier: 03596010511232
• UDI-Public: 03596010511232
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2021

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: 09/30/2023
• Device Model Number: 7210573
• Device Catalogue Number: 7210573
• Device Lot Number: 20200910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1