MAUDE Adverse Event Report: SMITH AND NEPHEW INC. TRIGEN INTERTAN DRILL

Model Number 71674070

Device Problem Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 05/04/2014

Event Type  malfunction  

Event Description

Physician did an imhs hip.The next day the spd supervisor noticed the 7mm starter drill looked as if some metal had been "shaved" as if it had been through a lathe.Drill sequestered.Physician was notified and ordered x-ray on the patient.Physician stated the drill operated well and there were no issues or resistance when drilling.

• Brand Name: TRIGEN INTERTAN DRILL
• Type of Device: DRILL
• Manufacturer (Section D): SMITH AND NEPHEW INC.; memphis 38116
• MDR Report Key: 3874097
• MDR Text Key: 4591962
• Report Number: MW5036581
• Device Sequence Number: 2
• Product Code: HSB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71674070
• Device Lot Number: UNREADABLE
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 73