MAUDE Adverse Event Report: CONMED CORPORATION INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	KBL191
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged broken kbl191 is not expected to be returned for evaluation and review.This complaint of broken device is unable to be verified and a root cause cannot be determined.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 was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 4 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: warnings: do not use excessive force on instruments to avoid damage or breakage during use.Do not use instruments to pry, as bending or breakage may occur.Do not use improperly or with excessive force, as accuracy may be compromised.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 kbl191 was being used during a acl reconstruction on 6aug20 when the device was "inserted guide per recommendations and the shaft snapped in half.Fragment was lodged in joint but easily removed with grasper.Delay of 1-min to remove fragment." there was no report of injury to the patient.There was no medical intervention or hospitalization caused by the event.The patient was reported as now recovering.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Corrected data: this data was updated accordingly since the device has been returned and evaluated: h3 - device has been evaluated by mfg.H6 - codes for type of investigation, investigation findings and investigation conclusion updated.H10 - includes evaluation statement of device.Manufacturing narrative: the returned device was evaluated, and examination found the device broken off at the welded shaft.Critical dimensions were inspected per print kbl191 and could not find any discrepancies.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: INFINITYTM ANTEROMEDIAL GUIDE L 9/10MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 10479809
• Report Number: 1017294-2020-00364
• Device Sequence Number: 2628346
• Product Code: LXH
• UDI-Device Identifier: 30845854902305
• UDI-Public: (01)30845854902305(11)200710(10)1105117
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

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 Model Number: KBL191
• Device Catalogue Number: KBL191
• Device Lot Number: 1105117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/09/2020
• Patient Sequence Number: 1
• Patient Weight: 62