MAUDE Adverse Event Report: STERILMED, INC. SHAVER BLADE FULL-RADIUS RESECTOR LARGE HUB YELLOW; ARTHROSCOPIC SHAVER SYSTEM BLADE, REPROCESSED

Catalog Number	LINC9248
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) was reviewed and no discrepancies were noted.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old male patient, underwent a right knee arthroscopy procedure with a shaver blade full-radius resector large hub yellow and second-degree burn occurred.The patient was brought to the operating room for a knee scope on the right knee.Procedure was going as planned with no issues and surgeon was using a full radius resector when both the surgical technician and the physician assistant (pa) noticed a burning smell.Scrub looked down and saw some smoke coming from the resector and immediately noticed that it was broken, no fire was noticed.She notified the surgeon, who stopped what he was doing and removed the instrument.The resector was inspected and found to be obviously broken.Surgeon and pa started to inspect the knee at the portal site and noted that there was some possible tearing.It was later determined that it was most likely a second degree burn at the incision site where the shaver was being used in the knee.The spot was measured, and pictures were taken.A new device, 3.5 fill radius shaver was opened, and the case continued and completed successfully without further incident.The physician¿s opinion on the origin of the smoke it was caused by heat generation and the burn was caused by the shaver.There was no specific procedural or patient circumstance that contributed to the break of the device.The patient was seen and treated at the facility wound clinic, however exact treatment is unknown.
Additional Manufacturer Narrative
Additional information was received via medwatch received on 11/16/2018.The burn measured 10mm wide and 20mm in length.Initial reporter also sent report to fda? was updated to yes since a medwatch was received on this event.(b)(4).
Additional Manufacturer Narrative
It was reported that a (b)(6) male patient, underwent a right knee arthroscopy procedure with a shaver blade full-radius resector large hub yellow and second-degree burn occurred.The product said to be involved was not received for evaluation.As the device was not returned for evaluation a thorough examination could not be performed.The device history record was reviewed and the records show that the device passed all visual & functional testing prior to being shipped to the account.A photograph of the involved product was provided.The image is too low a resolution (as well as out of focus) to zoom in on sections of the device to conduct an effective analysis.However, it can be assessed that the device's shaft, with the inner cannula fully inserted within the outer cannula, is bent to a significant degree.This is indicative of excessive force on the device's structure, likely from excessive torqueing of the product while in use.Unable to evaluate the bend to determine if this is a full bend or a partial/complete break and involves the butt weld joint (where two pieces of the cannula are welded together on the same plane) a characteristic of linvatec shavers.While the area appears bent, no conclusion could be made as to whether the device made contact with another metal device or hard object.The account reported that the device ¿burnt the patient¿.Cannot determine from the photo, how heat would have affected or came from the product.As the device was used on the patient, no conclusion could be determined as to a possible cause for their reported failures.The instructions for use for reprocessed powered arthroscopic accessories, which provides various warnings and precautions, it is noted to state, "do not operate the cutter, shaver, or burr at rpms in excess of those recommended.Do not operate without the flow of irrigation.Periodic irrigation of the tip of the burr or cutter is recommended to provide adequate cooling of the blade and to prevent accumulation of excised materials in the surgical site.Do not contact cutters, shavers, or burrs with metal objects as this may cause the device to break or shed metal.Excessive ¿side-loading¿ on the blade during use does not improve cutting performance, and in extreme cases, may result in wear and degradation of the inner blade.Excessive pressure may cause cutters, shavers, or burrs to bend or break which may in turn cause harm to the patient and/or operating room staff.¿ if device is received, a complete evaluation will be conducted.Manufacturer's ref.No: (b)(4).

• Brand Name: SHAVER BLADE FULL-RADIUS RESECTOR LARGE HUB YELLOW
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8055812
• Report Number: 2134070-2018-00111
• Device Sequence Number: 1654309
• Product Code: HRX
• UDI-Device Identifier: 10888551000192
• UDI-Public: 10888551000192
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K012536
• 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,Followup
• Report Date (Section B): 10/26/2018

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 Expiration Date: 03/15/2019
• Device Catalogue Number: LINC9248
• Device Lot Number: 2049547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 12/14/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 11/19/2018; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 84