MAUDE Adverse Event Report: CONMED CORPORATION 4.5MM X 19CM HPS SPHERICAL BUR; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	HPS-H001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The broken hps-h001 is not expected to be returned for evaluation and review.This complaint of broken device was verified via photographs that were received.The photographs were reviewed by manufacturing engineering and it was determined that the breakage was caused by excessive lateral force.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.There have been a total of 10 complaints for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use for this accessory's handpiece, the user is advised the following: precautions: do no apply excessive loading on the shaver blade or bur.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 sales representative reported on behalf of the customer that the hps-h001, 4.5mm x 19cm hps spherical bur, device broken mid-shaft during a hip arthroscopy surgery on (b)(6) 2018.It was reported that the device fragment/component was retrieved from the patient.The patient did not sustain any injury from this event.Further information obtained 18jun2018 found that the patient did not require prolonged hospitalization and the patient is listed as healthy.The procedure was completed as normal.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: 4.5MM X 19CM HPS SPHERICAL BUR
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7628379
• Report Number: 1017294-2018-00086
• Device Sequence Number: 13927818
• Product Code: GFA
• UDI-Device Identifier: 20845854020682
• UDI-Public: (01)20845854020682(17)230123(10)898656
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2018

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: Physician
• Device Expiration Date: 01/23/2023
• Device Catalogue Number: HPS-H001
• Device Lot Number: 898656
• 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: 05/25/2018
• Initial Report FDA Received Date: 06/22/2018
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 122