MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPIDER ANKLE STABILIZATION KITS; EXPANDER, SURGICAL, SKIN GRAFT

Model Number	72202931
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that when the patient was already asleep they went to open the invasive ankle straps (came in with the loan) and noticed that they went out of date in may 2017.They have now had to wake the patient up and will have to reschedule the case.
Additional Manufacturer Narrative
An evaluation was performed by smith and nephew and could confirm the customer complaint for the device is expired.It was determined that the ankle strap expiration date was not verified before shipment from the (b)(6).Service operation center.The sap system had an incorrect expiration date in it and because of that the system would have not flagged an issue at the time of shipment.Stock has been reviewed for any expired inventory and all items that were due to expire were scrapped.All appropriate personnel have been notified of this failure.This is the first complaint for this issue.Smith and nephew will continue to monitor for future trends.
Additional Manufacturer Narrative
H10/h11: the initial incident report was submitted with incorrect manufacturing site information and registration number (b)(4) (s+n andover).The correct manufacturing site information and registration number is (b)(4) (s+n oklahoma).Corrected data: d3 and g1 manufacturing site name, address and contact information.

• Brand Name: SPIDER ANKLE STABILIZATION KITS
• Common Device Name: EXPANDER, SURGICAL, SKIN GRAFT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 8100054
• Report Number: 3003604053-2018-00183
• Device Sequence Number: 13994706
• Product Code: FZW
• UDI-Device Identifier: 00885554018288
• UDI-Public: 00885554018288
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2020

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: 02/01/2018
• Device Model Number: 72202931
• Device Catalogue Number: 72202931
• Device Lot Number: 20140521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/10/2019; 01/10/2019
• Initial Report FDA Received Date: 11/23/2018
• Supplement Report FDA Received Date: 01/11/2019; 02/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1