MAUDE Adverse Event Report: STERILMED, INC. SHAVER BLADE FULL RADIUS ELITE MAROON; ARTHROSCOPE

Catalog Number	SMI7210499
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Account returned a sealed package, labeled for the identified product.It was observed that there was foreign material stuck to the cutting teeth of the shaver.Therefore, the reported issue was confirmed.The package was opened, and the synthetic debris was examined under a scope.It had similar color and physical characteristics of the protective gloves worn by the associates handling the product during its reprocessing.The device history record was reviewed; (b)(4) devices were reprocessed on this lot.There are no observed discrepancies and the final release criteria were met before this lot was released for distribution.There is no product from this lot remaining in available to ship (ats) status at the warehouse for possible distribution.(b)(4) devices from this lot were shipped to 2 customers.Removal of the remaining (b)(4) devices, that had less than six months expiration.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a piece of surgical glove was in the clipper of the shaver blade full radius elite maroon inside the packaging.Product was still sealed, and the material can be visibly seen through the plastic packaging.Therefore, the product was not opened or used on a patient.There was no patient consequence.This event has been assessed as a reportable event.

• Brand Name: SHAVER BLADE FULL RADIUS ELITE MAROON
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8480367
• Report Number: 2134070-2019-00123
• Device Sequence Number: 14101885
• Product Code: HRX
• UDI-Device Identifier: 10888551034531
• UDI-Public: 10888551034531
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/08/2019

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: 11/30/2019
• Device Catalogue Number: SMI7210499
• Device Lot Number: 2077045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1