MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DIAMOND RASP 90 DEG; ARTHROSCOPE

Model Number	014550
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee arthroscopy the diamond rasp was losing some metallic debris /flakes inside the patient's joint.The particles were successfully retrieved from the patient.There was an available backup device.Neither delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the reported 90 degree diamond rasp, used in treatment, has been returned for evaluation.The device is over eight years old and shows normal wear.Visual assessment of the distal tip using a stereo microscope did not show any evidence of material missing.Reported complaint cannot be confirmed.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.Further investigation is not warranted at this time.Per e-mail communication the metallic debris /flakes from the diamond rasp were successfully retrieved from the patient.The procedure was completed with a back-up device with no delay or patient injury.The device was returned for analysis and the reported issue could not be confirmed.Since the patient was not harmed and backup a device was available no further clinical assessment is warranted.

• Brand Name: DIAMOND RASP 90 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9832176
• Report Number: 1219602-2020-00524
• Device Sequence Number: 19017725
• Product Code: HRX
• UDI-Device Identifier: 03596010096111
• UDI-Public: 03596010096111
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K932460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 014550
• Device Catalogue Number: 014550
• Device Lot Number: 50393950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1