MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM L-P TIBIA PL 13H L 167MM; PLATE, FIXATION, BONE

Catalog Number	72463113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, there was a static threaded hole that disallowed a screw to lock.Screw tightened by hand.Delay 0-30 min, had backup.
Additional Manufacturer Narrative
The associated complaint device was not returned.Without the return of the implanted device the root cause of the reported failure is indeterminate.The two provided fluro images do not indicate a root cause to the reported complaint.It was reported that no patient harm or injury was sustained as a result of this device related incident.The plate remains implanted but the screws used during the procedure were not provided for evaluation.It was reported that the 0-30minute surgical delay due to the free hand closure, did not result in any patient harm.No additional medical assessment is warranted based on the information provided.Without the actual product involved our investigation cannot proceed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.If the devices are received in the future, this complaint can be re-opened.We consider this complaint closed.

• Brand Name: EVOS 3.5MM L-P TIBIA PL 13H L 167MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8214719
• Report Number: 1020279-2019-00037
• Device Sequence Number: 13949967
• Product Code: HRS
• UDI-Device Identifier: 00885556640432
• UDI-Public: 00885556640432
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2019

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 Catalogue Number: 72463113
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1