MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ASSEMBLY ENDOBUTTON INDICATOR; GAUGE, DEPTH

Model Number	72202544
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case: (b)(4).
Event or Problem Description
It was reported that during ligamentoplasty, the screw that allows the measurement scale to be placed on the meter body was placed backwards in the manufacturing process, which makes it impossible to measure the length of the femoral tunnel when preparing it in the surgical procedure.There was a change in surgical technique and no significant delay or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
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.There was a relationship found between the subject device and the reported incident.A review of the customer-supplied photographs was performed and observed the locking knob and the graduation markings are not correctly oriented with one another.The complaint was confirmed and the root cause was associated with cause traced to manufacturing.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the endobutton indicator assembly drawing shows the defined relationship of the tightening knob placement in reference to the laser markings.A review of risk management files found that the reported failure was documented appropriately.A correction in the form of a complaint notification has been issued to manufacturing management to mitigate future recurrences.No containment actions are recommended at this time.

• Brand Name: ASSEMBLY ENDOBUTTON INDICATOR
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10947411
• Report Number: 1219602-2020-01991
• Device Sequence Number: 3189751
• Product Code: HTJ
• UDI-Device Identifier: 03596010651556
• UDI-Public: 03596010651556
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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 Model Number: 72202544
• Device Catalogue Number: 72202544
• Device Lot Number: 50854863
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 06/23/2021
• 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: Required Intervention