MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS SPARE, STERILE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	2503-S
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that the implant box indicated an expiration date of january 2023 but the correct expiration date was january 2021.The label was printed incorrectly.The bone anchor operated as expected and this was noticed after procedure.
Additional Manufacturer Narrative
H6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review of this part number concluded this was an isolated event.A review of the device label revealed an expiration date of 2023-01-30.A review of risk management files found that the reported failure was documented appropriately.A review of the packaging storage stability report found the device has been validated for a shelf life of three years.After a review of internal records, it was confirmed that the expiration date for catalogue item 2503-s, bone anchors spare, sterile, lot 2050408 is january 2023 and the item was not expired at the time of implantation.Since no patient injuries are anticipated no further clinical/medical assessment is warranted at this time.The complaint was confirmed and the root cause was associated with manufacturing.There was a mismatch in the manufacturing production systems.An engineering change order was issued to correct the expiration date in the production database.

• Brand Name: BONE ANCHORS SPARE, STERILE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11996894
• Report Number: 3003604053-2021-00221
• Device Sequence Number: 1099052
• Product Code: MBI
• UDI-Device Identifier: 00854501006111
• UDI-Public: 854501006111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 2503-S
• Device Lot Number: 2050406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other