MAUDE Adverse Event Report: CONMED 5.5MM STERLING, SPHERICAL BUR, REDUCED HOOD; ARTHROSCOPIC SHAVER SYSTEM BLADE

Model Number	H9112RH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned by the user facility and no photographic evidence was provided; therefore, the reported failure could not be verified and a root cause cannot be conclusively determined.A review of the manufacturing documents verified the device was produced per current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified at the time of manufacture.A two-year review of complaint history revealed (b)(4) similar complaints, with (b)(4) devices, for this product family and failure mode.In that same timeframe, (b)(4) units of this product family have been sold worldwide, making the rate of occurrence of this failure (b)(4) percent, if all complaints were confirmed.The instructions for use advises the user of the following.Do not apply excessive loading to the shaver blades or bur.Cutting performance is not increased with force.Excessive force or using shaver blades or burs as a lever can cause damage to the device including permanent deformation, shedding of metal (wear), motor seizure and overheating.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The conmed sales representative reported on behalf of the user facility that during a shoulder case, the tip of the h9112rh bur broke off and fell into the patient.The tip was retrieved with a grasper.There was a 5 minute surgical delay.No patient injury was reported.Upon gathering additional information, it was reported the procedure and patient's recovery was as expected.This report is being raised on the basis of a reported malfunction with potential for injury with recurrence.

• Brand Name: 5.5MM STERLING, SPHERICAL BUR, REDUCED HOOD
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM BLADE
• Manufacturer (Section D): CONMED; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7659620
• Report Number: 1017294-2018-00100
• Device Sequence Number: 16647128
• Product Code: GFF
• UDI-Device Identifier: 10845854029640
• UDI-Public: (01)10845854029640(17)230315(10)914589
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: H9112RH
• Device Catalogue Number: H9112RH
• Device Lot Number: 914589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/03/2018
• Patient Sequence Number: 1