MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RALLY ALL IN ONE CEMENT GUN; DISPENSER, CEMENT

Catalog Number	71271610
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the rally cement gun was not strong enough to push 70gm of cement out.The gun broke due to the force exerted to get the cement out.Delay of less than 30 minutes and no backup available.
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 the device did not break inside or over the patient´s incision, 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.
Additional Manufacturer Narrative
We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re opened.

• Brand Name: RALLY ALL IN ONE CEMENT GUN
• Common Device Name: DISPENSER, CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8489933
• Report Number: 1020279-2019-01402
• Device Sequence Number: 1253498
• Product Code: KIH
• UDI-Device Identifier: 00885556582275
• UDI-Public: 00885556582275
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup,Followup
• Report Date (Section B): 09/23/2019

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 Catalogue Number: 71271610
• Initial Date Received by Manufacturer: 03/10/2019
• Supplement Date Received by Manufacturer: 06/20/2019; 06/20/2019
• Initial Report FDA Received Date: 04/07/2019
• Supplement Report FDA Received Date: 06/23/2019; 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR