MAUDE Adverse Event Report: STERILMED, INC. SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE; ARTHROSCOPE

Catalog Number	STR375-544-000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.(b)(4).
Event or Problem Description
It was reported that a patient underwent a knee arthroscopy partial meniscectomy procedure with a shaver blade aggressive plus formula series red/blue and the tip of the shaver fell off into the patient.The tip was successfully removed through a trocar, which slowed down the procedure.Another of the same device was used to complete the procedure.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a knee arthroscopy partial meniscectomy procedure with a shaver blade aggressive plus formula series red/blue and the tip of the shaver fell off into the patient.Additional information was received on july 22, 2019 that the device was discarded.Since the device was not returned for evaluation, no visual or functional analysis could not be conducted.Therefore, the reported issue could not be confirmed.A manufacturing record evaluation was performed for the finished device lot# 2081940, and no non-conformances were identified.Per the failure mode and effects analysis for orthopedic shavers after risk control measures, the potential cause of fragments of a device break/fall during procedure are device malfunction, physician misuse, misalignment/mismatch of shaft and sleeve.After risk control measures, the risk level is determined to be low/broadly acceptable.Manufacturer's ref.No: (b)(4).

• Brand Name: SHAVER BLADE AGGRESSIVE PLUS FORMULA SERIES RED/BLUE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8742164
• Report Number: 2134070-2019-00138
• Device Sequence Number: 1590989
• Product Code: HRX
• UDI-Device Identifier: 10888551030069
• UDI-Public: 10888551030069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K012536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: 11/07/2019
• Device Catalogue Number: STR375-544-000
• Device Lot Number: 2081940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1