MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DISPOSABLE KNIFE SHARP TIP; ACCESSORIES,ARTHROSCOPIC

Model Number	010650
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(6).
Event or Problem Description
It was reported that during a shoulder arthroscopy, an oxidation problem was found on the knife.The knife is usable and they were used in the patient but the oxidation is very annoying on the camera screen.A back up device was available to complete the procedure without delay.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 010650 sharp tip disposable knife used for treatment but was not available for evaluation.Per instruction for use (ifu) ¿prior to use, inspect the device to ensure it is not damaged.¿ ifu contains precautionary statements and recommendations for proper use of product.Photos provided showed discoloration.Unfortunately the product was opened and complaint could not be confirmed, as it was unknown whether the item was used prior.Complaint history review indicated no similar allegations for the lot number reported aside from the other reported with this complaint.Batch review did not indicate a condition or product/procedure failure that supported the allegation.No root cause related to the manufacture of this device was confirmed.Product met specifications upon release to distribution.No further investigation is warranted at this time.Occurrence is monitored by surveillance.Per clinical / mi: reportedly while using the disposable knife, an oxidation problem was found.Two photos have provided for review and confirm a color variation.A backup device was used to complete the procedure with no delay or patient injuries being reported.Since no patient harm is being alleged and no further harm is anticipated, no further assessment is warranted at this time.

• Brand Name: DISPOSABLE KNIFE SHARP TIP
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9720651
• Report Number: 1219602-2020-00231
• Device Sequence Number: 18921196
• Product Code: NBH
• UDI-Device Identifier: 03596010032720
• UDI-Public: 03596010032720
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2020

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 Expiration Date: 06/06/2024
• Device Model Number: 010650
• Device Catalogue Number: 010650
• Device Lot Number: 2034315
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1