MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BLT ASSY. 4 POINT DIRECTOR; ACCESSORIES,ARTHROSCOPIC

Model Number	7205525
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the 4 point director had the calibration marks no longer legible.There is not a case reported but this has been an ongoing issue.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One acl director angled bullet assembly used for treatment, was not returned for evaluation.Due to product unavailability, evaluation was limited.The information provided states, ¿the blt assy angled director acl and the 4 point director had the calibration no longer legible¿.An exact root cause cannot be determined with confidence.Instruction for use documentation contains precautionary statements and recommendations for proper use of product.Per instruction for use: prior to use, inspect the device to ensure it is not damaged.Do not use a damaged device.Insert the bullet into the bottom of the guide with the flat side of the bullet knob facing down.Complaint history review indicated, no other complaints of this failure was found.Batch review was unattainable without a valid lot number reported.No indications suggest the product did not meet specifications upon release to distribution.

• Brand Name: BLT ASSY. 4 POINT DIRECTOR
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10168856
• Report Number: 1219602-2020-00936
• Device Sequence Number: 1762456
• Product Code: NBH
• UDI-Device Identifier: 03596010373243
• UDI-Public: 03596010373243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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: 7205525
• Device Catalogue Number: 7205525
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1