MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOSCPC CANN.DRL.BIT 4.5 STRL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 7207315

Device Problem Dull, Blunt (2407)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the endoscopic cannulated drill bit 4.5mm was blunt during first use and there was residue left in the patient.The procedure was successfully completed without delay using a back-up device.No apparent ham has reached the patient.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Event Description

It was reported that the endoscopic cannulated drill bit 4.5mm was blunt during first use.The procedure was successfully completed without delay using a back-up device.The information about the patient's bone quality and possible additional bone holes are unknown.No pieces were broken off in patient or anywhere off the drill.No patient harm or complications reported.

Manufacturer Narrative

H10: additional information was received that identified that this event should be re-evaluated for mdr reporting.The new information states that nothing broke off inside the patient or in any part of the device, the device was only dull.The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event.This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.

• Brand Name: ENDOSCPC CANN.DRL.BIT 4.5 STRL
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9957017
• MDR Text Key: 187525937
• Report Number: 1219602-2020-00646
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 03596010425409
• UDI-Public: 03596010425409
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

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
• Device Operator: Health Professional
• Device Model Number: 7207315
• Device Catalogue Number: 7207315
• Device Lot Number: 2044715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 05/07/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other