MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL TIP WIRE WITH STOPPER 1.8MMX385MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71070369
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that two frame surgeons in glasgow royal infirmary have both used the bayonet style wires and reported that drill tips are blunt and it takes more effort to push them through the bone.Also, the thread fill up with bone.They were used and left in patient until (b)(6) 2019, when the frame was removed due to a continued pin site problem which also required multiple doses of oral antibiotics.
Additional Manufacturer Narrative
It was reported that the frame was removed due to a continued pin site problem which also required multiple doses of oral antibiotics.The affected drill tip wires, used in treatment, were not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.The devices were sterilized according to sterilization release documentation from quality control.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.A clinical analysis noted that the undated x-ray and mri were provided which show abnormalities at the bone pin hole sites.Also a photo was provided that shows discoloration at the pin site and scarring from what appeared to be a pin site infection.A review of instructions for use revealed the alleged failure is previously identified in the potential adverse events.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The potential root causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.The product development team has been made of aware of this issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: DRILL TIP WIRE WITH STOPPER 1.8MMX385MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8802675
• Report Number: 1020279-2019-02700
• Device Sequence Number: 18946756
• Product Code: KTT
• UDI-Device Identifier: 00885556289044
• UDI-Public: 00885556289044
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K130479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 71070369
• Device Catalogue Number: 71070369
• Device Lot Number: 18HM22748A
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 04/12/2020
• 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