MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CEMENT DRILL 4.5MM; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	71369007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip broke inside the distal femoral (right femoral canal) canal of the patient.The surgeon had to operate longer to try and remove the partial instrument.Delay of 25 minutes reported.
Event or Problem Description
It was reported that the tip broke intra-operative inside the distal femoral (right femoral canal) canal of the patient due to wear and tear.The surgeon had to operate longer to try and remove the partial instrument.Delay of 25 minutes reported.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: CEMENT DRILL 4.5MM
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8883004
• Report Number: 1020279-2019-03008
• Device Sequence Number: 11523732
• Product Code: MDM
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71369007
• Device Catalogue Number: 71369045
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 07/24/2019; 08/18/2020
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 11/25/2019; 08/19/2020
• 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: Hospitalization; Required Intervention