MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AIMER ENDOFEMORAL 3MM OFFSET (BLUE); ACCESSORIES,ARTHROSCOPIC

Model Number	72201713
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a knee arthroscopy, the surgeon pulled the knee to insert the guide and the endo femoral aimer broke.All pieces were removed from the patient.No delay was reported.It was not reported if a smith & nephew device was available.It was not reported if the procedure was successfully completed.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported 3mm offset endofemoral aimer, intended for use in treatment, has not been returned for evaluation.Without the reported product, a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot; there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
H3, h6: the reported 3mm offset endofemoral aimer, used in treatment, has been returned for evaluation.The device lot is over six years old.Visual assessment of the device confirmed the reported breakage.The off-set tip has broken off of the shaft at the solder joint.The tip is bent slightly.The shaft is bent and the proximal end of the aimer is damaged.The condition of the device indicates it was subjected to excessive force and torque during use.Per the device instructions for use under precautions ¿as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: AIMER ENDOFEMORAL 3MM OFFSET (BLUE)
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9777857
• Report Number: 1219602-2020-00454
• Device Sequence Number: 2778466
• Product Code: NBH
• UDI-Device Identifier: 03596010608185
• UDI-Public: 03596010608185
• 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: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2020

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 Model Number: 72201713
• Device Catalogue Number: 72201713
• Device Lot Number: 50502209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020; 05/21/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/07/2020; 05/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR