MAUDE Adverse Event Report: STERILMED, INC.; ARTHROSCOPE

Model Number SMI7206011

Device Problems Vibration (1674); Metal Shedding Debris (1804); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

It was reported that during an arthroscopy left knee menisectomy when using the device after five seconds there were metal shavings "everywhere," noise and vibration.Using on tissue and shavings from the device were visualized.A second device was used with the same results.The shavings were cleaned out and removed believed to be by irrigation.There was no patient injury.See related mfr report #(b)(4).

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon evaluation, the device was viewed under magnification.There was no notable damage to the cutting surfaces.There were no obvious signs of metal fatigue such as pitting or heavy scouring marks.There were light scouring marks present on the inside of the outer subassembly, but no corresponding marks were noted on the inner subassembly indicating that the marks were not caused during the event.The inner shaver slid easily into the outer shaft, and there was no metal to metal contact during a spin/drop test.The device connected to the generator with no issues.When the device was run, the outer subassembly vibrated slightly at high speed.It was noted that the lettering on the rear of the outer subassembly was blurred by the motion.No shavings were produced during examination.Subsequent to being run on the generator the device was re-examined for cracks in the hub, and none were seen.The device alignment was inspected and was found to be acceptable.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4293924
• MDR Text Key: 18925143
• Report Number: 2134070-2014-00191
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: SMI7206011
• Device Catalogue Number: 7206011
• Device Lot Number: 1705286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1