MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORBIT INCISOR PLUS,EP-1 (6/BX); SAW, POWERED, AND ACCESSORIES

Model Number	7205687
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during a knee arthroscopy, the 4.5 orbit incisor plus was defective and it was shedding metal inside the joint.The surgeon stated the metal in the joint was successfully removed.The procedure was successfully completed without delay using another shaver blade of the same type (orbit) 4.5 mm.No patient injuries 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 single 7205687 orbit incisor plus ep-1 blade used in treatment, was returned for evaluation.This device is sold as a box of six; not intended for individual sale.There is no outer damage aside from light surface scratches.The ratchet collar was in place upon receipt.It is unknown whether the device was previously separated in attempt to inspect it.The proximal area is subject to heat.Per ifu: ¿irreversible damage will result from any attempt to disassemble curved blades.Periodic irrigation of the blade is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Ensure that suction of 128 mmhg minimum is flowing while the instrument is running¿.No obstruction was found.There was a proximal band on the inner blade where it had tarnished.Silver plating process is used to produce a device with less friction.Visual tarnish observation is cosmetic.Silicone is for additional lubrication between inner and outer blades.The silicone and silver improve performance of the device and do not have an adverse effect on the patient.It is possible that the tarnish shed, although there were no wear bands noted.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition, product, procedure failure that supported the allegation.

• Brand Name: ORBIT INCISOR PLUS,EP-1 (6/BX)
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9729359
• Report Number: 1219602-2020-00238
• Device Sequence Number: 2513037
• Product Code: HAB
• UDI-Device Identifier: 03596010373229
• UDI-Public: 03596010373229
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 04/07/2020

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: 7205687
• Device Catalogue Number: 7205687
• Device Lot Number: 50810134
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1