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

Catalog Number	LINC9248
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
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 review and no discrepancies related to the reported issue were uncovered.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a knee arthroscopy procedure with a ¿shaver blade full-radius resector large hub yellow¿.The shaver blade left metal shavings in the patient during surgery.The physician was able to rub them out of the patient.The shaver blade was also making a clicking sound during use.There was no patient consequence reported.The clicking sound was assessed as not reportable.The metal shavings left in the patient was assessed as a reportable malfunction.
Additional Manufacturer Narrative
The biosense webster inc.Failure analysis lab received the device for evaluation on 10/22/2018.Therefore, populated device available for evaluation?, is device returned to manufacturer? and date device returned to manufacturer.Investigation summary: it was reported that a patient underwent a knee arthroscopy procedure with a ¿shaver blade full-radius resector large hub yellow¿.The shaver blade left metal shavings in the patient during surgery.The physician was able to rub them out of the patient.The shaver blade was also making a clicking sound during use.There was no patient consequence reported.While there are contaminants present and indications of use, the device appears visually acceptable and there was no indication on metal degradation or contact with other metal.During the evaluation of insertion and spinning the inner part inside the outer part's sleeve, there was no observation of sound, such as a clicking, heard.The proximal end of the inner shaft was placed on a small lint-free cloth on the work station.70% ipa was sprayed directly into the shaft of the inner from the distal end of the inner.A channel cleaning brush was placed down into the shaft of the inner from the distal end.The lint-free cloth was inspected under 36x magnification.No debris was observed or found.Unable to verify the presence of any remaining metal shavings.The device history record (dhr) was review and no discrepancies related to the reported issue were uncovered.There are no observed findings and no conclusions determined which could explain the presence of shavings originally reported at the time of its use.Manufacturer's reference number: (b)(4).

• Brand Name: SHAVER BLADE FULL-RADIUS RESECTOR LARGE HUB YELLOW
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 7900193
• Report Number: 2134070-2018-00107
• Device Sequence Number: 285020
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

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: No Information
• Device Expiration Date: 03/15/2019
• Device Catalogue Number: LINC9248
• Device Lot Number: 2049547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1