MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HALF PIN 4MM X 20MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	122700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to the breakage of half pins.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to the breakage of half pins.The associated devices were not returned for analysis.Therefore a product evaluation could not be performed.No batch number was provided, therefore the device history record review cannot be completed.Complaint history review could not be performed with any accuracy due to lack of batch number.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved, no batch information available as well as no medical information provided, our investigation of this report is inconclusive.No further investigation warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: HALF PIN 4MM X 20MM
• 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: 8739216
• Report Number: 1020279-2019-02474
• Device Sequence Number: 11396633
• Product Code: KTT
• UDI-Device Identifier: 03596010069344
• UDI-Public: 03596010069344
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K920024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/25/2019

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 Catalogue Number: 122700
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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