MAUDE Adverse Event Report: CONMED CORPORATION PRESSFT DRILL BIT, 2.1MM, HIP; BIT, SURGICAL

Catalog Number	NDB21H
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual examination of the returned, used device confirmed the reported problem and found the device broken off at the tip.The broken tip is approximately 0.500 of an inch and was not returned for evaluation.Without the return of the machined drill tip, examination is not able to identify any issues with the machining process.No discrepancies with the dimension or the straightness of the drill were found.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 one complaint, regarding this one device, 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: precautions: inspect instrument prior to use to ensure it is in good physical condition and functions properly.There should be no loose, broken or misaligned parts.Exercise care in the use of the device to minimize side or bending loads.Do not use excessive force on instruments to avoid damage or breakage during use.Avoid unintended contact with other surgical instruments during use to prevent damage or breakage.Inspect instrument after use to ensure it has not been damaged.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 ndb21h, pressft drill bit, 2.1 mm, hip, device drill tip broke off while drilling a hole for the anchor and was not able to be removed from patient.This event took place during a hip arthroscopy on (b)(6) 2018 causing a 10-minute delay in the procedure.The procedure was completed successfully using an alternate device.The tip was not removed from that patient due to being too difficult to remove being that it was embedded in the bone.It was reported that there was no injury to the patient or the user.No extended hospitalization or surgical intervention was required.This report is being raised on the basis of injury due to the tip being left in the patient.

• Brand Name: PRESSFT DRILL BIT, 2.1MM, HIP
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd.; largo FL 33773
• MDR Report Key: 7843937
• Report Number: 1017294-2018-00142
• Device Sequence Number: 11124192
• Product Code: GFG
• UDI-Device Identifier: 10845854027936
• UDI-Public: (01)10845854027936(11)170626(10)846966
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: NDB21H
• Device Lot Number: 846966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other