MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANN BARREL GUIDE-2 PIECE; PLATE, FIXATION, BONE

Model Number	71110060
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, guide wire got stuck in barrel guide during use.Device appears to be bent.No injury has been reported.Procedure had a delay of less than 30 minutes and it is unknown how the procedure concluded.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.Therefore, product analysis could not be performed at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.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.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.G1.

• Brand Name: CANN BARREL GUIDE-2 PIECE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10367516
• Report Number: 1020279-2020-03712
• Device Sequence Number: 11602712
• Product Code: HRS
• UDI-Device Identifier: 03596010173089
• UDI-Public: 03596010173089
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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: 71110060
• Device Catalogue Number: 71110060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1