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

Model Number	014550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during an arthroscopy the tip of the diamond broke inside the patients joint, pieces were removed with the shaver.The procedure was completed with the same device and a significant delay was reported.No further complications reported.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, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A review of batch records using the ncmr database caweb4 confirmed no abnormalities were reported on this lot during manufacture.A complaint history review concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
H10 h3, h6 the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.A visual inspection of the returned device found that it was returned outside of its original packaging.The laser etching on the side of the device confirms the product identification information.The device is worn from use, and the shaft is slightly bent.There is not diamond tip with the device.The complaint was confirmed.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.

• Brand Name: DIAMOND RASP 90 DEG
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11113532
• Report Number: 1219602-2021-00018
• Device Sequence Number: 1059834
• Product Code: HRX
• UDI-Device Identifier: 03596010096111
• UDI-Public: 03596010096111
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 014550
• Device Catalogue Number: 014550
• Device Lot Number: 50126772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 05/21/2021; 10/19/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 05/24/2021; 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention