MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 8.5MM X 32CM; NAIL, FIXATION, BONE

Model Number	71655032
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the tibia nail placement was performed retrogradely with an entry point in the calcaneus, sure shot technique was performed for placement of two proximal locking screws, and placement of two distal screws with directional arm at the calcaneus level.The specialist decided to place the tibia nail of 8.5 320 mm because when performing the corrective osteotomies in the tibia at the distal and diaphyseal level, the hind foot nail did not cover the length required for fixation.The surgery was finish using an alternate technique.No adverse events or health problems have occurred to the patient.There was a delay below 30 minutes and no backup device was necessary to finish the surgery.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: META-NAIL TIBIAL 8.5MM X 32CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9886436
• Report Number: 1020279-2020-01031
• Device Sequence Number: 14167466
• Product Code: JDS
• UDI-Device Identifier: 03596010585462
• UDI-Public: 03596010585462
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/02/2020

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: No Information
• Device Model Number: 71655032
• Device Catalogue Number: OR71655032
• Device Lot Number: 17LM04861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1
• Patient Age: 28 YR