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

Model Number 72202544

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event Description

It was reported that, during an acl surgery, it was noticed the scale on "endobutton indicator assembly" was printed on the wrong side and therefore, it was not possible to view the size through the instrument window.The procedure was successfully completed without significant delay using the same faulty device estimating the femoral tunnel.No patient injuries or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).¿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.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 concluded this was a repeat issue.The complaint was confirmed and the root cause is associated with manufacturing.A complaint notification was sent to manufacturing management to mitigate future occurrences.¿.

• Brand Name: ASSEMBLY ENDOBUTTON INDICATOR
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11726695
• MDR Text Key: 247548909
• Report Number: 1219602-2021-00965
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 03596010651556
• UDI-Public: 03596010651556
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 72202544
• Device Catalogue Number: 72202544
• Device Lot Number: 50854863
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/06/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1