MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VORTEX CEMENT GUN; DISPENSER, CEMENT

Model Number	71272001
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the cement gun did not progress forward handle sticks.Surgeon had to push cement out by hand.There was a two minute procedural delay.There was no smith & nephew available.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device was manufactured in 2017 and exhibits signs of extensive wear/usage.The functional evaluation confirmed the stated failure mode.The trigger mechanism is sticking and therefore will not function as intended.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there is no risk to the patient with using the cement gun manually, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: VORTEX CEMENT GUN
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9079868
• Report Number: 1020279-2019-03421
• Device Sequence Number: 2477371
• Product Code: KIH
• UDI-Device Identifier: 03596010515018
• UDI-Public: 03596010515018
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2020

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: 71272001
• Device Catalogue Number: 71272001
• Device Lot Number: 17KM15215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Initial Date Received by Manufacturer: 08/23/2019
• Supplement Date Received by Manufacturer: 08/23/2019; 08/23/2019; 08/23/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/06/2019; 10/11/2019; 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1