MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PROFORE LITE SYSTEM KIT CASE 8; BANDAGE, ELASTIC

Model Number	66000415
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported, the coban layer of fifteen (15) profore lite system kit case 8 are so tight it's very difficult to get a proper wrap, therefore, is impacting the ability to use.This problem was noticed before treatment and a back up was available; therefore, patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device has not been returned for complaint evaluation.The images supplied for review, do not clearly highlight the reported issue, however following a review of the manufacturing process, we are able to confirm the reported complaint and relate the issue to a manufacturing problem.A review of the manufacturing records and processes was performed, with a root cause of inadequate standard operating procedure assigned.A documentation review has been conducted, confirming previous complaints of this nature, with corrective actions assigned and completed.The complained product was released prior to the actions being imitated.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.

• Brand Name: PROFORE LITE SYSTEM KIT CASE 8
• Common Device Name: BANDAGE, ELASTIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12892929
• Report Number: 8043484-2021-01982
• Device Sequence Number: 4364494
• Product Code: FQM
• UDI-Device Identifier: 05031844002498
• UDI-Public: 05031844002498
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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 Model Number: 66000415
• Device Catalogue Number: 66000415
• Device Lot Number: 1278045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown