MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 5MM OFFSET (RED); ACCESSORIES,ARTHROSCOPIC

Model Number	72201715
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, the top of the aimer endofemoral 5mm offset (red) broke, inside the patient, during arthroscopy procedure.It was removed with grasper tip.The procedure was successfully completed without delay but it is unknown if a backup device was available.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, 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.There was a relationship found between the subject device and the reported incident.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 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 risk management files found that the reported failure was documented appropriately.A review of the customer provided image revealed the distal tip of the device has been broken.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed.Factors, which could have contributed to the complaint event, include an application of unintended inappropriate or excessive force to the device.No containment or corrective actions are recommended at this time.

• Brand Name: AIMER ENDOFEMORAL 5MM OFFSET (RED)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12647973
• Report Number: 1219602-2021-02298
• Device Sequence Number: 11886841
• Product Code: NBH
• UDI-Device Identifier: 03596010608208
• UDI-Public: 03596010608208
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 72201715
• Device Catalogue Number: 72201715
• Device Lot Number: 50390875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown