MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HDL ASSY DRCTR ACL GDE.; ACCESSORIES,ARTHROSCOPIC

Model Number	7205517
Medical Device Problem Codes	Failure to Align (2522); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the set up before the surgery, it was noticed an inaccuracy of the tibia tip aimer, 4 point bullet and acufex tibia tip aimer have been all set up, 2.4mm guide pin was used and it was noticed that the exit of the guide did not hit the tip of the aimer, it slightly deviated to the tip.No patient injuries or delay reported.Smith and nephew back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection of the returned device found that it is not in its original packaging.The device shows light wear from use, the laser etchings are legible.There are no deformities visible.A functional assessment of the device found it functions as designed with reference devices.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this ti h11: h2: corrected data on: h6 (health effect - clinical code, health effect - impact code & medical device problem code).

• Brand Name: HDL ASSY DRCTR ACL GDE.
• 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: 10767700
• Report Number: 1219602-2020-01721
• Device Sequence Number: 3525149
• Product Code: NBH
• UDI-Device Identifier: 03596010373250
• UDI-Public: 03596010373250
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/08/2024

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: 7205517
• Device Catalogue Number: 7205517
• Device Lot Number: 50835560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 11/01/2020
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown